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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS AntiSARSCoV2 Total Reagent

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  Class 2 Device Recall VITROS AntiSARSCoV2 Total Reagent see related information
Date Initiated by Firm July 17, 2020
Create Date August 07, 2020
Recall Status1 Terminated 3 on July 16, 2021
Recall Number Z-2770-2020
Recall Event ID 86038
Product Classification Reagent, coronavirus serological - Product Code QKO
Product VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
Code Information Lots 0010-0037
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ortho Care Technical Solutions Center
800-421-3311
Manufacturer Reason
for Recall		 The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
FDA Determined
Cause 2		 Process control
Action On July 17, 2020, the firm issued Urgent Product Correction Notification letters to affected customers. Customers were informed of the potential for erroneous patient sample results, calibration errors, and QC failures when using the impacted product. Customers were asked to do the following; " Visually inspect affected VITROS Anti-SARS-CoV-2 Total (Lots 0010-0037) and IgG (Lots 0010-0013) Reagent Packs to ensure correct reagent bottle configuration " Set aside any pack in which the reagent bottles are positioned incorrectly, so the lot number and pack id can be provided to Ortho. Complete and submit the enclosed Request for Credit Form, including the pack information, to receive credit for an affected pack. " Complete the Confirmation of Receipt form no later than July 28, 2020. " Post this notification by each system that processes an affected lot. " Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 47,271 sales units
Distribution Worldwide distribution - US Nationwide distribution.
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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