Z-0120-2022Class II

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

Name: Z-0120-2022 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the...
Creator: Ortho Clinical Diagnostics Inc
Published: 2021-09-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-09-10 / Terminated

FDA source

Ortho Clinical Diagnostics Inc began a recall of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600... on 2021-09-10. FDA classified it as Class II and gives the reason as "VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0120-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-10
Posted: 2021-10-15
Terminated: 2024-02-13
Recalling firm: 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
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: US: 64 OUS: 200
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.
Product codes and lots: Lot Number: 0040(*and potentially future lots) UDI: 10758750034475 Exp. Date: 19NOV2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0120-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0120-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-15

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)