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.
This recall has been terminated (originally issued July 17, 2020).
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- July 17, 2020
- Terminated
- July 16, 2021
- Recall Number
- Z-2770-2020
- Quantity
- 47,271 sales units
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide distribution.
Lot / Code Info
Lots 0010-0037
Root Cause
Process control
Action Taken
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.