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N/A
HARDY DIAGNOSTICS · Model L36 · UDI-DI 00819398022279
10
510(k) clearances
1,021
Adverse events
29
Recalls
66
Facilities
Description
BHI (Brain Heart Infusion) Agar Slant, 5.5ml fill, 16x100mm tube, order by the package of 20 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2021-02-16 | Vectornate USA Inc | Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility. |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t |
| 2019-04-17 | Remel Inc | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t |
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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.