VITROS Immunodiagnostic Products Troponin I ES Calibrators
- Recall Initiated
- June 5, 2023
- Posted
- August 8, 2023
- Recall Number
- Z-2358-2023
- Quantity
- 4,013 units
Reason for Recall
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Info
Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.
Root Cause
Process control
Action Taken
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 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.