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Bayer Healthcare, Diagnostics Division

Country not established

Devices
3
FDA recalls
11

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Bayer Healthcare, Diagnostics Division makes

The company produces automated clinical chemistry analyzers and reagents, including glucose oxidase and hexokinase assays for blood glucose measurement, as well as CO₂ calibrators and diluents for laboratory use. It also supplies quality control materials for hepatitis A virus (HAV) total antibody testing on immunoassay platforms.

These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances and PMA submissions. The portfolio is listed in the FDA’s regulatory databases, and the company operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 11 recalls initiated by Bayer Healthcare, Diagnostics Division, the earliest on 2006-01-20 and the most recent on 2006-09-08. By recorded status: 11 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 11 recalls.

  • 2006

    • 8 Sep 2006 Z-0351-2007 Unclassified (pre-2012) Terminated Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Distribution: Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia,…
      Full distribution text Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
      Submission number: K990346
    • 8 Sep 2006 Z-0352-2007 Unclassified (pre-2012) Terminated Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint. Distribution: Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia,…
      Full distribution text Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
      Submission number: K990346
    • 8 Sep 2006 Z-0353-2007 Unclassified (pre-2012) Terminated Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint. Distribution: Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia,…
      Full distribution text Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
      Submission number: K990346
    • 16 Mar 2006 Z-1376-06 Unclassified (pre-2012) Terminated The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram. Distribution: Worldwide distribution-Domestic consignees consist of hospitals and clinical laboratories. Foreign countries (units):…
      Full distribution text Worldwide distribution-Domestic consignees consist of hospitals and clinical laboratories. Foreign countries (units): Canada (1), China (4), Singapore (1), Malaysia (2), Thailand (1), Taiwan (1), Vietnam (1), Australia (3), Korea (25), Japan (25), Israel (4), Saudi Arabia (4), Russia (1), Turkey (1), United Arab Emirates (1), South Africa (2), United Kingdom (31), Germany (1), Poland (9), Norway (1), Spain (48), Finland (7), Denmark (4), Portugal (14), Italy (5), Netherlands (3), France (46), Ireland (4), India (7), Austria (1).
      Submission number: K971998
    • 17 Feb 2006 Z-1448-06 Unclassified (pre-2012) Terminated Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect. Distribution: Worldwide including USA and Puerto Rico. Submission number: K990346
    • 17 Feb 2006 Z-1449-06 Unclassified (pre-2012) Terminated Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect. Distribution: Worldwide including USA and Puerto Rico. Submission number: K990346
    • 17 Feb 2006 Z-1450-06 Unclassified (pre-2012) Terminated Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect. Distribution: Worldwide including USA and Puerto Rico. Submission number: K990346
    • 20 Jan 2006 Z-0682-06 Unclassified (pre-2012) Terminated When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display. Distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia,…
      Full distribution text USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
      Submission number: K031560
    • 20 Jan 2006 Z-0683-06 Unclassified (pre-2012) Terminated When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display. Distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia,…
      Full distribution text USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
      Submission number: K031560
    • 20 Jan 2006 Z-0684-06 Unclassified (pre-2012) Terminated When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display. Distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia,…
      Full distribution text USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
      Submission number: K031560
Show all 11 recalls

  • 2006

    • 20 Jan 2006 Z-0685-06 Unclassified (pre-2012) Terminated When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display. Distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia,…
      Full distribution text USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
      Submission number: K031560

Frequently asked questions

How many devices does Bayer Healthcare, Diagnostics Division have in the registry?

The registry currently lists 3 devices for Bayer Healthcare, Diagnostics Division. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bayer Healthcare, Diagnostics Division's devices?

Among its 3 most recently registered devices, Bayer Healthcare, Diagnostics Division has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Bayer Healthcare, Diagnostics Division's devices fall under?

Among its 3 most recently registered devices, the classes recorded for Bayer Healthcare, Diagnostics Division's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Bayer Healthcare, Diagnostics Division?

FDA recall records list 11 recalls initiated by Bayer Healthcare, Diagnostics Division, the most recent initiated on 8 Sep 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Bayer Healthcare, Diagnostics Division in the registry?

The most recently registered devices listed for Bayer Healthcare, Diagnostics Division include ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE, CO2 CALIBRATOR/DILUENT and ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS.

Generated automatically from registry data and not verified by a human reviewer.