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HARDY DIAGNOSTICS · Model K38 · UDI-DI 00816576020249
JTZ
Prescription
10
510(k) clearances
106
Adverse events
8
Recalls
10
Facilities
Description
MUELLER HINTON BROTH For the preparation of suspensions for disk diffusion sensitivity testing.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-12 | Remel, Inc | Products may contain contamination, which may result in a darker or brown media color. |
| 2018-05-04 | Thermo Fisher | Product may fail performance testing for S aureus ATCC 43300. |
| 2017-11-02 | Remel Inc | Product may have incorrect cation information detailed on the product label. |
| 2011-04-20 | Becton Dickinson & Co. | Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens. |
| 2009-12-08 | Remel, Inc | The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591. |
| 2009-06-04 | Trek Diagnostic Systems | Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA |
| 2008-09-22 | Trek Diagnostic Systems | Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S inte |
| 2005-07-28 | Becton Dickinson & Co. | Microbiological media for antibiotic susceptibility testing gives false test results. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.