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N/A
HARDY DIAGNOSTICS · Model PL092HD · UDI-DI 00819398027977
10
510(k) clearances
39
Adverse events
3
Recalls
19
Facilities
Description
Latex Agglutination Cards, for rapid latex agglutination testing Disposable white cards with ten raised reaction circles used for rapid latex agglutination testing.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-20 | Cypress Medical Products LLC | Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices. |
| 2009-04-06 | Binax, Inc. dba IMPD | Potential for false positive Strep A results. |
| 2004-06-11 | Abbott Laboratories HPD/ADD/GPRD | False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control. |
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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.