Ortho Clinical Diagnostics recalls Urine Electrolyte Diluent (Product Code 1112352) due to potential instability when stored in 2mL cups for 7 days. Affected lots have expiry dates from Feb 2020 to Aug 2021.
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 urine electrolyte diluent (Product Code 1112352) because it may become unstable when stored in 2mL cups for 7 days. This could affect lab test accuracy for sodium and potassium levels.
The diluent may become unstable when stored in 2mL cups for 7 days, potentially leading to inaccurate lab test results for sodium and potassium levels. This instability does not cause physical harm but affects test accuracy.
Lab users who have the Urine Electrolyte Diluent (Product Code 1112352) with expiry dates from February 2020 to August 2021. Those performing urine tests on VITROS 250/350/5,1 FS/4600 or VITROS 5600/XT 7600 systems are most at risk.
Check for Product Code 1112352 with expiry dates: V6391 (Feb 2020), W6895 (Sep 2020), X7127 (Jan 2021), or Y7593 (Aug 2021). The product is used to dilute urine specimens for sodium and potassium analysis on specific lab systems.
Verify the product code and expiry date on the container to confirm if it's affected.
The diluent may become unstable when stored in 2mL cups for 7 days, potentially causing inaccurate lab test results for sodium and potassium levels.
Using the product after 7 days in a 2mL cup may lead to inaccurate test results, but it does not pose a physical safety risk.
This product is used with VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
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-0740-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0740-2020 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.
