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HARDY DIAGNOSTICS · Model K73 · UDI-DI 00819398026239
10
510(k) clearances
3,143
Adverse events
2
Recalls
17
Facilities
Description
Fluid Thioglycollate with Hemin and Vitamin K, 16x125mm tube, order by the package of 20 For the cultivation of aerobic, microaerophilic, and anaerobic microorganisms in normally sterile materials.
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.