Recall Z-2358-2023 ยท MMI Immunoassay Method, Troponin Subunit
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Troponin I ES Calibrators
| Date | Aug 8, 2023 (initiated Jun 5, 2023) |
| Status | Open, Classified |
| Reason | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| Root cause | Process control |
| Action | Customers were sent a recall notification by mail dated 06/05/2023. The notification that customers immediately discontinue use of affected devices and discard any remaining inventory. Any discarded product will be replaced by QuidelOrtho or credit will be provided. Customers are asked to return the provided Confirmation of Receipt Form no later than 06/12/2023. If affected devices were further distributed customers are asked to forward the provided notification to those downstream customers. This notice is to be posted by all VITROS Systems until the expiration of affected devices, which is 0 |
| Quantity | 4,013 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |