VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
FDA Recall Z-2357-2023 · Posted 2023-08-08
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Recalling FirmORTHO-CLINICAL DIAGNOSTICS
Recall StatusOpen, Classified
Product CodeMMI
Date Initiated2023-06-05
Product Quantity4,013 units
Reason for Recall
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Firm 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 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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