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Bayer Healthcare, Diagnostics Division FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Bayer Healthcare, Diagnostics Division has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bayer Healthcare, Diagnostics Division" is on file.

What these totals cover: FDA records filed under the name "Bayer Healthcare, Diagnostics Division". Records filed under related names are not included; see Related names.

Latest recall: Z-3147-2026 · Jul 31, 2026 · filed under Bayer Medical Care
Latest 510(k): Sep 29, 2004

Newer recall under related name Bayer Medical Care: Jul 31, 2026, Z-3147-2026.

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	2	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	0	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Bayer Healthcare, Diagnostics Division above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Bayer Medical Care	Same company group	10	11	13	1	Jul 31, 2026 (Z-3147-2026)
Bayer Healthcare	Same company group	11	55	25	2	Nov 7, 2016 (Z-0927-2017)
Bayer	Same company group	1	96	40	2	Apr 3, 2014 (Z-1673-2014)
Bayer Healthcare Manufacturing	Same company group	0	0	5	0	—
Bayer De Mexico, S.A De C.V	Same company group	0	0	4	0	—
Bayer Medical	Same company group	0	0	1	0	—

Recent 510(k) clearances

2 510(k) clearances from Jan 8, 2004 to Sep 29, 2004.

K-Number	Device	Date
K042015	ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE	Sep 29, 2004
K033643	CO2 CALIBRATOR/DILUENT	Jan 8, 2004

Bayer Healthcare, Diagnostics Division and the FDA: common questions

Has Bayer Healthcare, Diagnostics Division received an FDA warning letter?

No FDA warning letter addressed to the name "Bayer Healthcare, Diagnostics Division" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Bayer Healthcare, Diagnostics Division received an FDA Form 483?

FDA has not published a Form 483 for "Bayer Healthcare, Diagnostics Division" in its reading room. FDA publishes some Form 483s, not all of them.

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