CLASS II Device recall · Reported 27 Oct 2021 · FDA Enforcement Report

Vitros Immunodiagnostic Products Anti-Sars-CoV-2 IgG recalled

Ortho Clinical Diagnostics is recalling Vitros Immunodiagnostic Products Anti-Sars-CoV-2 IgG Quantitative Controls (Ivd)- For use, distributed nationwide in the US. The recall was initiated on 10 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 0040(*and potentially future lots) UDI: 10758750034475 Exp. Date: 19NOV2021

Quantity recalledUS: 64 OUS: 200

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0120-2022
FDA event ID: 88737
Recalling firm: Ortho Clinical Diagnostics, Raritan, NJ
Classification: Class II
Status: Terminated
Recall initiated: 10 Sep 2021
FDA classified: 15 Oct 2021
Reported: 27 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

10 Sep 2021	Recall initiated by company
15 Oct 2021	Classified by FDA	+35 days
27 Oct 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado District of Columbia Florida Idaho Kansas Kentucky Louisiana Maine Michigan Missouri Mississippi New York Tennessee Texas West Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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