Z-0450-2021Class II

VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator -

Name: Z-0450-2021 VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator -
Creator: Ortho Clinical Diagnostics Inc
Published: 2020-09-30
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-09-30 / Terminated / root cause: manufacturing process

FDA source

Ortho Clinical Diagnostics Inc began a recall of VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune... on 2020-09-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0450-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-30
Posted: 2020-11-13
Terminated: 2023-12-07
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
Product code: QMN Covid-19 Multi-Analyte Antigen Device
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ortho Clinical Diagnostics issued Urgent Product Correction Notice on 30 Sept 2020 via(CL2020-246) of the issue and instructed as follows: If they are unable to calibrate (now or in the future) using an affected lot of VITROS Anti-SARS-CoV-2 IgG Calibrator Ortho will replace their remaining inventory as indicated on their Confirmation of Receipt form. NOTE: If they have a successful calibration, and quality control results are acceptable, the laboratory may continue using the affected lots for qualitative detection of IgG antibodies to SARS-CoV-2. If they are using the affected product to qualify units as high titer for CPT, consult with your medical director to determine if they should continue testing while waiting for their replacement product. Ortho will replace or credit their remaining inventory as indicated on their Confirmation of Receipt form. Post this notification by each system that processes the affected lots of VITROS Anti-SARS-CoV-2 IgG Calibrator or Control. Complete the enclosed Confirmation of Receipt form no later than October 9, 2020. Indicate the quantity of their remaining inventory to be replaced or credited. Please forward this notification if the product was distributed outside of their facility
Quantity in commerce: 651 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
Product codes and lots: Lot Number/ Exp. Date: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205 27-NOV-20 0220 03-DEC-20 0230 03-DEC-20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0450-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0450-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-13
Z-0451-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-13

Product code QMN

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)