Recall Z-2169-2018 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
BioMerieux SA
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to ident
| Date | Mar 23, 2018 |
| Status | Terminated |
| Reason | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers. |
| Root cause | Environmental control |
| Action | The firm, Biomerieux, sent an "Urgent product removal notice" letter on April 23 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately acknowledge receipt (AR) of this FSCA. 2. Identify all countries and customers for which you are responsible that are impacted by this FSCA. 3. Define additional actions required (e.g. Translate customer letter, send to impacted countries/customers, etc.) 4. Distribute the customer letter to all customers that have received the products 5. Discard any impacte |
| Quantity | 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS |
| Distribution | International distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101946 | VIDAS TOXO IGG AVIDITY bioMerieux, Inc., May 18, 2011 |