Lower riskMedical device recall · FDA · Published March 9, 2023
Ortho-Clinical VITROS SARS-CoV-2 Antibody Calibrators May Cause Delayed Patient Results
Ortho-Clinical recalls VITROS SARS-CoV-2 antibody calibrators with incorrect calibrator levels that may delay patient test results. Affected products include specific data release versions and lot numbers.
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
“Ortho-Clinical VITROS SARS-CoV-2 Antibody Calibrators May Cause Delayed Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58773-ortho-clinical-vitros-sars-cov-2-antibody-calibrators-may-cause. Based on FDA recall #Z-1396-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1396-2023%22&limit=1).
The FDA announced on March 9, 2023, that Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators due to a hazard of delayed patient results. The recall involves calibrators programmed onto Assay Data Disks with incorrect numbers of calibrator levels.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
Product Code: 6199976
UDI: 10758750034581
Lot Codes/Expiration Dates: 0230 (22-Feb-2023), 0240 (22-Mar-2023), 0250 (26-Apr-2023)
Assay Data Disks Data Release Versions: 6213 through 6218
Units affected: 256
The hazard
The recall is due to the incorrect number of calibrator levels (2) set for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks. This error results in delayed patient results.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has had 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical VITROS LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025). Other recent recalls of similar products include Fujirebio Lumipulse G pTau 217 Plasma Calibrators (December 11, 2025).
How to tell if you have this one
Check for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators with data release versions 6213 through 6218. Products with lot numbers 0230 (exp 22-Feb-2023), 0240 (exp 22-Mar-2023), or 0250 (exp 26-Apr-2023) are affected.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your VITROS calibrators have data release versions 6213 through 6218 and the specified lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, AZ, CA, GA, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Georgia, New York.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1396-2023 (March 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1396-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.