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N/A
HARDY DIAGNOSTICS · Model G141 · UDI-DI 00816576025053
10
510(k) clearances
538
Adverse events
6
Recalls
24
Facilities
Description
PDA with Fildes and Nafcillin, 15x100mm Plate, 19ml. Hardy Diagnostics Peptic Digest Agar (PDA) with Fildes and Nafcillin is an enrichment medium recommended for the selective isolation of Haemophilus species.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-05 | Remel, Inc | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. |
| 2018-08-02 | Acumedia Manufacturers, Inc. | The product is labeled with an incorrect expiration date. |
| 2016-03-21 | Hardy Diagnostics | Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to produc |
| 2013-06-06 | Becton Dickinson & Co. | Microbiological identification media may exhibit reduced levels of Vancomycin. |
| 2013-06-06 | Becton Dickinson & Co. | Microbiological identification media may exhibit reduced levels of Vancomycin. |
| 2013-06-06 | Becton Dickinson & Co. | Microbiological identification media may exhibit reduced levels of Vancomycin. |
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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.