Recall Z-0864-2023 ยท LYR Helicobacter Pylori
Biomerieux Inc
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
| Date | Jan 4, 2023 (initiated Nov 9, 2022) |
| Status | Open, Classified |
| Reason | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Root cause | Storage |
| Action | Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments. 3. Stop using and scrap any remaining impacted products in your inventory. a. Request product replacement o |
| Quantity | 4 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS BIOMERIEUX, Jul 9, 2015 |