Recall Z-0924-2018 ยท MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
Wiener Laboratories
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
| Date | Nov 10, 2017 |
| Status | Open, Classified |
| Reason | Internal program testing shows that product may not reach the indicated expiration date. |
| Root cause | Nonconforming Material/Component |
| Action | On about November 10, 2017, customers were notified via email of the recall. Instructions include to examine inventory and cease distribution of the device, make arrangements to return affected devices, acknowledge receipt of the recall notification, and notify customers if further distributed. |
| Quantity | 1,563 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 Wiener Laboratories Saic, Feb 11, 2004 |