Ortho Clinical Diagnostics recalls 7% BSA (Bovine Serum Albumin) diluents that may become unstable when stored in 2mL cups for 7 days. Affected products include VITROS 250/350/5,1 FS/4600 and VITROS 5600/XT 7600 systems.
Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days
Ortho Clinical Diagnostics is recalling 7% Bovine Serum Albumin (BSA) diluents that could become unstable when stored in 2mL cups for 7 days. This instability may affect lab test accuracy if used in certain blood analyzers.
The 7% BSA diluent may become unstable when stored in a 2mL cup for 7 days, potentially leading to inaccurate lab test results. This instability does not cause physical harm but affects the reliability of test outcomes.
Lab technicians and healthcare facilities using VITROS 250/350/5,1 FS/4600 and VITROS 5600/XT 7600 blood analyzers with the recalled BSA diluents. The risk is low as the issue is related to storage conditions, not immediate harm.
Check for Product Code 8262487 (7% BSA) or Product Code 1110352 (Urine Electrolyte Diluent) in 2mL cups. The affected lots have expiry dates from November 2019 to January 2021.
Identify if your diluent has Product Code 8262487 (7% BSA) or 1110352 (Urine Electrolyte Diluent).
Ensure the diluent is not stored in a 2mL cup for more than 7 days to prevent instability.
The diluent may cause inaccurate lab test results if used in VITROS 250/350/5,1 FS/4600 and VITROS 5600/XT 7600 blood analyzers.
7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (Product Code 1110352) with expiry dates from November 2019 to January 2021.
No, but ensure the diluent is not stored in a 2mL cup for more than 7 days to maintain stability.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0739-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0739-2020 from Ortho Clinical Diagnostics. 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.
