Lower riskMedical device recall · FDA · Published May 8, 2024
Ortho-Clinical VITROS Vitamin B12 Range Verifier May Cause Test Failures
Ortho-Clinical recalls VITROS Vitamin B12 Range Verifier Lot 1200 RV Level 2 due to potential range verification failure. No patient results affected; no action needed for most users.
The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
Ortho-Clinical is recalling a specific lot of their VITROS Vitamin B12 Range Verifier because it may cause range verification failures. This could delay patient test results if users switch to an alternate method, but past results are unaffected and no action is needed for most users. Read more at govinfonow.com/recall/55156-ortho-clinical-vitros-vitamin-b12-range-verifier-may-cause-test.
“Ortho-Clinical VITROS Vitamin B12 Range Verifier May Cause Test Failures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55156-ortho-clinical-vitros-vitamin-b12-range-verifier-may-cause-test. Based on FDA recall #Z-2019-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2019-2024%22&limit=1).
The FDA announced on May 8, 2024, that Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 due to potential range verification failure. The agency stated the issue may delay patient test results if users must switch to an alternate verification method.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly
Lot Number: 1200
Product Code: 6800872
UDI-DI: 10758750000937
Exp. Date: 30-Sep-2024
The hazard
The FDA said the results generated by Lot# 1200 RV Level 2 may cause range verification failure, which is detectable when the product fails to meet the required range during processing. This issue affects the upper limit range verification but has no impact on VITROS Immunodiagnostic Products Vitamin B12 assay performance.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Recent brand recalls include VITROS LAC Slides (2025-07-29), VITROS Ca Slides (2025-07-09), and VITROS OP Reagent Gen 15 (2025-06-12). Other recent recalls of similar products include Vivoo Test Strips Recall (2025-11-22), Vivoo Protein Test Recall (2025-11-22), and Vivoo pH Test Recall (2025-11-22).
How to tell if you have this one
Check for the product code 6800872 and lot number 1200 RV Level 2 on the device. The device was sold with an expiration date of September 30, 2024.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for product code 6800872 and lot number 1200 RV Level 2 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide and the country of Columbia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-2019-2024 (May 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2019-2024 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.