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N/A
HARDY DIAGNOSTICS · Model Y41 · UDI-DI 00819398025829
1
510(k) clearances
173
Adverse events
2
Recalls
29
Facilities
Description
Moeller's Decarboxylase Base (control), 5ml fill, 16x125mm tube, order by the package of 20 For the differentiation of gram negative enteric bacilli based on the decarboxylation reaction of amino acids. A control tube for use with Y42, Y43, and Y44.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-11 | Remel, Inc | The products may contain surface and subsurface contamination of Listeria monocytogenes. |
| 2017-03-24 | Remel Inc | Confirmed complaint of surface contamination of Listeria monocytogenes. |
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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.