Ortho-Clinical recalls VITROS TIBC Calibrator Kits and Fe Slides with potential 80 ug/dL lower TIBC results starting from GEN 26 slides. Affected kits and slides may cause inaccurate blood test results.
Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
Ortho-Clinical is recalling VITROS TIBC Calibrator Kits and Fe Slides that could cause blood test results to be 80 ug/dL lower than expected. This affects patients using these products for iron-related blood tests.
The recalled Fe Slides (GEN 26 and newer) cause TIBC results to be approximately 80 ug/dL lower than other generations. This shift could lead to inaccurate blood test results for iron-binding capacity, potentially affecting diagnosis and treatment decisions.
Healthcare facilities using VITROS 250/350/5,1, 4600/XT 3400, or 5600/XT 7600 chemistry systems with the recalled calibrator kits and Fe Slides. Patients receiving blood tests for iron-related measurements are most at risk.
Check for the product codes: VITROS TIBC Kit (Product No: 7541) or Fe Slides (Product Nos: 1924547, 1515808, 6802198). The affected slides are all current and new lots with specific lot numbers listed in the recall notice.
Identify if your VITROS TIBC Calibrator Kit or Fe Slides match the product codes and lot numbers listed in the recall notice.
The recall is due to a potential shift in TIBC results by approximately 80 ug/dL when using newer generations (GEN 26 and above) of VITROS Fe Slides, which could lead to inaccurate blood test results.
Using the recalled Fe Slides (GEN 26 and newer) may cause TIBC results to be 80 ug/dL lower than expected, potentially affecting iron-related diagnosis and treatment decisions.
Check the product codes and lot numbers listed in the recall notice to determine if your items are affected. The recall does not require immediate action but should be addressed to ensure accurate test results.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1295-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1295-2021 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.
