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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products TroponinI ES Calibrators

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 Class 2 Device Recall VITROS Immunodiagnostic Products TroponinI ES Calibratorssee related information
Date Initiated by FirmJune 05, 2023
Date PostedAugust 08, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2358-2023
Recall Event ID 92662
510(K)NumberK062838 K992366 
Product Classification Immunoassay method, troponin subunit - Product Code MMI
ProductVITROS Immunodiagnostic Products Troponin I ES Calibrators
Code Information Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
Felindre Meadows
Bridgend United Kingdom
For Additional Information ContactJoe Falvo
585-453-3452
Manufacturer Reason
for Recall		Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
FDA Determined
Cause 2		Process control
ActionCustomers 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.
Quantity in Commerce4,013 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MMI
510(K)s with Product Code = MMI
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