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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 Calibrators see related information
Date Initiated by Firm June 05, 2023
Date Posted August 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-2358-2023
Recall Event ID 92662
510(K)Number K062838  K992366  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product VITROS 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 Contact Joe 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
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.
Quantity in Commerce 4,013 units
Distribution Worldwide distribution - US Nationwide and the country of Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MMI and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS
510(K)s with Product Code = MMI and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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