Lower riskMedical device recall · FDA · Published May 3, 2021
Ortho-Clinical VITROS CoV2 Ag Calibrator Recall: Unexpected Calibration Failures
Ortho-Clinical recalls VITROS CoV2 Ag calibrator (Product Code 619995:10758750033591) due to potential calibration failures when used with SARS-CoV-2 Ag Reagent Packs. Affected units may show incorrect test results.
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, INc.513 Technology Blvd · Rochester, NY 14626-3601
“Ortho-Clinical VITROS CoV2 Ag Calibrator Recall: Unexpected Calibration Failures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62609-ortho-clinical-vitros-cov2-ag-calibrator-recall-unexpected-calibration-failures. Based on FDA recall #Z-1688-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1688-2021%22&limit=1).
The FDA announced on May 3, 2021, that Ortho-Clinical Diagnostics Inc. is recalling VITROS CoV2 Ag calibrator (Product Code 6199950) due to potential unexpected failed calibration. The recall affects Lot 0020 distributed worldwide and in several U.S. states.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS CoV2 Ag calibrator
Product Code: 6199950
Lot: 0020
Unique Identifier: 10758750033591
The hazard
Ortho-Clinical investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Fujirebio Lumipulse G pTau 217 Plasma Calibrators (Dec. 11, 2025), Siemens Dimension Creatinine Flex Reagent Cartridge (March 18, 2026), and Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators (Dec. 11, 2025).
How to tell if you have this one
Check for Product Code 6199950 with Lot 20 (Unique Identifier 10758750033591). The calibrator is used in labs for COVID-19 testing with VITROS SARS-CoV-2 Ag Reagent Packs.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Status
Verify if the calibrator shows correct calibration codes when used with the SARS-CoV-2 Ag Reagent Pack.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, CA, IA, IL, LA, MO, MS, TX, WI, and the countries of Colombia, India, Japan, Italy, Spain, Portugal, France.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Illinois, Iowa, Louisiana, Mississippi, Missouri, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1688-2021 (May 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1688-2021 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.