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 Quantita
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics Inc. is recalling VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls used to monitor performance of VITROS ECi/ECiQ/3600 Immunodiagnostic Systems. The controls were found to fall outside the expected control range, which could result in delayed test results. The affected lot number is 0040 and potentially future lots with expiration date November 19, 2021. A total of 64 units were distributed in the US across 19 states, and 200 units were distributed internationally across 20 countries including Canada, Australia, Brazil, Mexico, and several European nations.
The product recall record does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
Reason for recall: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results 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. Quantity: US: 64 OUS: 200 Lot/code info: Lot Number: 0040(*and potentially future lots) UDI: 10758750034475 Exp. Date: 19NOV2021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.