Lower riskMedical device recall · FDA · Published October 15, 2021
Ortho-Clinical Diagnostics VITROS Anti-HBc IgM Controls Recall: Potential for Delayed Test
Ortho-Clinical Diagnostics recalls VITROS Anti-HBc IgM Controls (Lot 1690) due to possible delayed test results from incorrect troubleshooting. No safety risk but may affect lab results.
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
“Ortho-Clinical Diagnostics VITROS Anti-HBc IgM Controls Recall: Potential for Delayed Test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61675-ortho-clinical-diagnostics-vitros-anti-hbc-igm-controls-recall-potential. Based on FDA recall #Z-0247-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0247-2022%22&limit=1).
The FDA announced on Oct. 15, 2021, that Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Anti-HBc IgM Controls due to a potential for delayed results from incorrect troubleshooting information in the controls values booklet. The agency issued recall number Z-0247-2022 for the Class III voluntary recall.
Ortho-Clinical Diagnostics confirmed that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklets contained information for the incorrect product. While patient test accuracy is not affected, this error creates a potential for delayed results due to troubleshooting Quality Control results.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has issued 53 other recalls since July 10, 2017. Recent similar product recalls include the Aniara Diagnostica ZYMUTEST HIA IgG Kit (April 1, 2026) and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay (July 13, 2026). Other recent recalls of similar products include the Vivoo Protein Test (Nov. 22, 2025).
How to tell if you have this one
Check for Product Code 6801427 with Lot Number 1690 on the control vial or booklet. These controls are used with VITROS ECi/ECiQ/3600 or VITROS 5600/XT 7600 Integrated Systems.
Brand
Ortho-Clinical Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Control Lot Number
Look for Lot 1690 on the control vial or booklet to identify affected units.
Where it went and when
Where it was distributed
Distributed in 19 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Missouri, New Jersey, New York, Oklahoma, South Carolina, South Dakota, Texas, Utah, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0247-2022 (October 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0247-2022 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.