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HARDY DIAGNOSTICS · Model K234 · UDI-DI 00819398021135
10
510(k) clearances
3,141
Adverse events
2
Recalls
17
Facilities
Description
Thioglycollate with H & K, 8mL, 16x100mm tube, 20 tubes.box (Thioglycollate without indicator with hemin and vitamin K) For the cultivation of bacteria, including fastidious anaerobes. Filtered to remove dead bacteria and debris.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-02-19 | Becton Dickinson & Co. | In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms. |
| 2004-09-27 | Remel, Inc. | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) |
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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.