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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products AntiSARSCoV2 IgG Quantitative Controls

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  Class 2 Device Recall VITROS Immunodiagnostic Products AntiSARSCoV2 IgG Quantitative Controls see related information
Date Initiated by Firm September 10, 2021
Create Date October 15, 2021
Recall Status1 Terminated 3 on February 13, 2024
Recall Number Z-0120-2022
Recall Event ID 88737
Product Classification Reagent, coronavirus serological - Product Code QKO
Product VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)-
For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2.
Product Code: 6199966
Code Information Lot Number: 0040(*and potentially future lots) UDI: 10758750034475 Exp. Date: 19NOV2021
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 Us Highway 202
Raritan NJ 08869-1424
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
FDA Determined
Cause 2		 Under Investigation by firm
Action Ortho Clinical Diagnostics issued on 10 September 2021 an "Important Product Correction Notification" letter to consignees who received VITROS Anti-SARS-CoV-2 IgG Quantitative Control, lot 0040 (Ref. CL2021-235) stating reason for notification, health risk and action to take: While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results. If standard troubleshooting does not resolve the out-of-range QC results, your facility would be unable to utilize the VITROS Anti-SARS-CoV-2 IgG Quantitative test. Note: If QC results are within the acceptable range, your facility may continue to use VITROS Anti-SARS-CoV-2 IgG Quantitative Controls Lot 0040 with VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Lot 0030. Resolution VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Lots 0035 and 0040 are expected to be available mid-late September 2021. The values currently published in the Control Value Booklet provided with VITROS Anti-SAR-CoV-2 IgG Quantitative Controls Lot 0040 are not appropriate for use with Reagent Lots 0035 and 0040. Reagent lot specific control ranges for VITROS Anti-SARS-CoV-2 IgG Quantitative Controls Lot 0040 have been established for upcoming VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Lots 0035 and 0040 and are published on the enclosed Control Value Sheet. These revised values must be used in place of the values currently published in the Control Value Booklet provided with VITROS Anti-SARS-CoV-2 IgG Quantitative Controls Lot 0040. An additional lot of VITROS Anti-SARS-CoV-2 IgG Quantitative Controls is also expected to be available in late September 2021. Ortho will communicate additional lot specific control ranges as future VITROS Anti-SARS-CoV-2 IgG Quantitative Controls and Reagent lots become available. REQUIRED ACTION " Complete the enclosed Confirmation of Receipt form no later than September 21, 2021. o If your facility c
Quantity in Commerce US: 64 OUS: 200
Distribution Worldwide Distribution: US (Nationwide) in states of: AL, AR, AZ, CA, CO, DC, FL, ID, KS, KY, LA, ME, MI, MS, MO, NY, TN, TX and WV; and OUS (Foreign) in countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, and The Netherlands.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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