Recall Z-0928-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Biomerieux Inc
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
| Date | Oct 22, 2019 |
| Status | Terminated |
| Reason | Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software. |
| Root cause | Software design |
| Action | The firm initiated their field action by an email to their subsidiaries on 10/22/2019. The subsidiaries then notified their customers by 2-day express via Fed Ex. In the US customer letter, customers are instructed to check their software version. If the VIDAS 3 software version is between 1.2.0 and 1.3.1, customers are instructed to check the archiving mode. If the archiving mode is Automatic When Results are Reported then customers are instructed how to configure the workaround, and to contact bioMerieux if the customer has the incorrect software configuration. bioMerieux then instructs |
| Quantity | 738 units |
| Distribution | US |
| 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 |