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U.S. Department of Health and Human Services

Class 2 Device Recall AntiSARSCoV2 IgG Quantitative Reagent Pack

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  Class 2 Device Recall AntiSARSCoV2 IgG Quantitative Reagent Pack see related information
Date Initiated by Firm May 26, 2022
Create Date July 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1367-2022
Recall Event ID 90408
Product Classification Reagent, coronavirus serological - Product Code QKO
Product Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿
ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems.
Product Code: 6199960
Code Information UDI-DI :10758750034413. All expired, in-date and future released lots
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact SAME
585-453-3000
Manufacturer Reason
for Recall		 On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Ortho Clinical Diagnostics issued Important Correction Notification letter (CL2022-135) on May 26, 2022. Letter states reason for recall, health risk and action to take: When using VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack, do not store on-analyzer for longer than 6 weeks. " Until a lot update occurs, OAS for VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack will temporarily require manual monitoring and removal of reagent packs from analyzer no longer than 6 weeks after packs have been opened and loaded onto the analyzer. " Complete the enclosed Confirmation of Receipt form no later than June 9, 2022. " Post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System in your laboratory until further notice. " Please forward this notification if VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311
Quantity in Commerce 20858
Distribution Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
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.
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