ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Brand
ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom
Lot Codes / Batch Numbers
Product Code: 6802301, UDI-DI: 10758750002504, Lot No.: 4800, Expiration Date: 10-Jun-2023.
Products Sold
Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023.
ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom is recalling VITROS Immunodiagnostic Products Troponin I ES Reagent Pack due to Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026