VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the…

Date

Oct. 27, 2021

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ortho Clinical Diagnostics Inc

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

Reason

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results

Distribution pattern

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

Codes and lots

Lot Number: 0040(*and potentially future lots) UDI: 10758750034475 Exp. Date: 19NOV2021

Recall started

Sept. 10, 2021

Device type

Reagent, Coronavirus Serological

Root cause (FDA)

Under Investigation by firm

What the company told customers

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

Recall number

Z-0120-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0120-2022. The agency record governs; check it and the company before acting.