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HardyFlask™
HARDY DIAGNOSTICS · Model X22 · UDI-DI 00819398024181
10
510(k) clearances
534
Adverse events
6
Recalls
24
Facilities
Description
LJ (Lowenstein Jensen) Media, 50ml plastic HardyFlask™, order by the package of 20 Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium 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.