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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic ProductsSARSCoV2 IgG Calibrator

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  Class 2 Device Recall VITROS Immunodiagnostic ProductsSARSCoV2 IgG Calibrator see related information
Date Initiated by Firm September 30, 2020
Create Date November 13, 2020
Recall Status1 Terminated 3 on December 07, 2023
Recall Number Z-0450-2021
Recall Event ID 86573
Product Classification COVID-19 Multi-Analyte Antigen Device - Product Code QMN
Product VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories--
Product Code (Unique Identifier): 6199920
(10758750033362)
Code Information Lot Number/ Exp. Date: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205 27-NOV-20 0220 03-DEC-20 0230 03-DEC-20
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information Contact SAME
908-218-1300
Manufacturer Reason
for Recall		 Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Ortho Clinical Diagnostics issued Urgent Product Correction Notice on 30 Sept 2020 via(CL2020-246) of the issue and instructed as follows: If they are unable to calibrate (now or in the future) using an affected lot of VITROS Anti-SARS-CoV-2 IgG Calibrator Ortho will replace their remaining inventory as indicated on their Confirmation of Receipt form. NOTE: If they have a successful calibration, and quality control results are acceptable, the laboratory may continue using the affected lots for qualitative detection of IgG antibodies to SARS-CoV-2. ¿ If they are using the affected product to qualify units as high titer for CPT, consult with your medical director to determine if they should continue testing while waiting for their replacement product. Ortho will replace or credit their remaining inventory as indicated on their Confirmation of Receipt form. ¿ Post this notification by each system that processes the affected lots of VITROS Anti-SARS-CoV-2 IgG Calibrator or Control. ¿ Complete the enclosed Confirmation of Receipt form no later than October 9, 2020. Indicate the quantity of their remaining inventory to be replaced or credited. Please forward this notification if the product was distributed outside of their facility
Quantity in Commerce 651 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
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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