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.
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.
The device may fail to meet the required range during processing, causing verification failures. This could lead to delays in patient test results if users switch to an alternate verification method. However, past patient results remain unaffected and the device does not impact assay performance.
Users of the VITROS Vitamin B12 Range Verifier Lot 1200 RV Level 2 are affected. Laboratory staff and healthcare providers who use this device for vitamin B12 testing are most at risk of delayed results if they switch methods.
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.
Look for product code 6800872 and lot number 1200 RV Level 2 on the device.
No action is needed for most users as past patient results are unaffected and the device does not impact assay performance.
The recall does not mention any risk of injury; it only addresses potential delays in test results.
Past patient results are unaffected, but there is a potential for delays if you switch to an alternate verification method.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2019-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2019-2024 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
