CLASS II Device recall · Reported 25 Nov 2020 · FDA Enforcement Report

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

Ortho Clinical Diagnostics is recalling Vitros¿ Immunodiagnostic Products Anti-Sars-CoV-2 IgG Control, distributed nationwide in the US. The recall was initiated on 30 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number/ Exp. Date: 0110 25-NOV-20

Quantity recalled691 units (OUS)

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-0451-2021
FDA event ID: 86573
Recalling firm: Ortho Clinical Diagnostics, Raritan, NJ
Classification: Class II
Status: Terminated
Recall initiated: 30 Sep 2020
FDA classified: 13 Nov 2020
Reported: 25 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

30 Sep 2020	Recall initiated by company
13 Nov 2020	Classified by FDA	+44 days
25 Nov 2020	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

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

Product as listed by the FDA

VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number/ Exp. Date: 0110 25-NOV-20

Where was it sold?

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.

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.

Other products in this recall event

1 other product · FDA event 86573

Reported	Class	Recall	Company	Reason	Where
25 Nov 2020	CLASS II	Vitros Immunodiagnostic Products-Sars-CoV-2 IgG Calibrator recalled	Ortho Clinical Diagnostics	Other	Nationwide

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