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Bayer Corp.

United StatesFDA applicant, unverified

Devices
96
FDA recalls
2

What Bayer Corp. makes

Bayer Corp. manufactures in-vitro diagnostic assays and systems for laboratory testing, including hormone assays like estradiol and complexed prostate-specific antigen (CPSA), as well as chemistry and immunology tests for systems such as the Bayer Advia 1650 and Technicon Immuno 1. The company also produces point-of-care diagnostic devices, such as the Clinitek HCG and microalbumin test strips, and blood glucose monitoring systems like the Glucometer Elite XL. Additional offerings include rapid diagnostic tools like the RapidPoint 400 system and assays for conditions like toxoplasmosis.

These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

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

Catalogue96

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FDA recalls2

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

FDA recall records list 2 recalls initiated by Bayer Corp., the earliest on 2003-09-26 and the most recent on 2014-04-03. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. 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.

  • 2014

    • 3 Apr 2014 Z-1673-2014 Class II Terminated There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008. Distribution: Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany,…
      Full distribution text Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
      Submission number: K073051

  • 2003

    • 26 Sep 2003 Z-0066-04 Unclassified (pre-2012) Terminated Potential for bias shift in pO2 values due to air bubble in sample path Distribution: Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands,…
      Full distribution text Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland
      Submission number: K020616