Home › HARDY DIAGNOSTICS › N/A
N/A
HARDY DIAGNOSTICS · Model Z175 · UDI-DI 00819398028639
10
510(k) clearances
211
Adverse events
21
Recalls
27
Facilities
Description
PYR Test Kit, 100 tests, with 20ml chromogenic developer, on paper disks A rapid test for Group A Strep and Enterococcus, both of which are PYR positive, all other streps are negative. A more reliable test for Group A Strep than bacitracin, the L-pyrrolidonyl -B-napthylamide impregnated disks serve as a substrate for the detection of pyrrolidonyl peptidase. Contains: PYR Test Disks (100) 00819398027038 PYR Test Disk Vial (1) 10819398027035 PYR Chromagenic Solution 20mL (1) 00819398028622
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.