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N/A
HARDY DIAGNOSTICS · Model W169 · UDI-DI 00816576027408
10
510(k) clearances
535
Adverse events
6
Recalls
24
Facilities
Description
BCYE (Buffered Charcoal Yeast Extract) Selective Agar with GPCV antibiotics, for Legionella, 26ml fill, 15x100mm plate, order by the package of 10 (Buffered Charcoal Yeast Extract Agar with Glycine, Vancomycin, Polymyxin, and Cycloheximide) For the selective isolation of Legionella spp.
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.