Bayer Corp.
United StatesFDA applicant, unverified
- Devices
- 96
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 96 devicesShowing 1-50 of 96
FDA recalls
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.
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.
Full distribution text
- 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.
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
Full distribution text
- 26 Sep 2003 Z-0066-04 Unclassified (pre-2012) Terminated Potential for bias shift in pO2 values due to air bubble in sample path
Frequently asked questions
How many devices does Bayer Corp. have in the registry?
The registry currently lists 96 devices for Bayer Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bayer Corp.'s devices?
Among its 50 most recently registered devices, Bayer Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Bayer Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bayer Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bayer Corp.?
FDA recall records list 2 recalls initiated by Bayer Corp., the most recent initiated on 2014-04-03. 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 Corp. in the registry?
The most recently registered devices listed for Bayer Corp. include ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM, COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM, 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM and CLINITEK HCG TEST STRIPS.