Ortho Clinical Diagnostics recalls VITROS Chemistry Calibrator Kit 2 for VITROS 250/350/5,1 FS/4600/XT 3400 systems. This kit may cause inaccurate sodium results in urine tests. Affected lots include 277 (Dec 2019), 288 (May 2020), 298 (Nov 2020), and 219 (Jul 2021).
Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
Ortho Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 2 for certain laboratory systems. This kit may cause inaccurate sodium results in urine tests if used with specific lots. Affected units could lead to incorrect test results if not replaced.
The calibrator kit may produce negatively biased sodium results in urine tests. This means test results could show lower sodium levels than actually present, potentially affecting diagnosis and treatment decisions.
Lab technicians and healthcare facilities using VITROS 250/350/5,1 FS/4600/XT 3400 or VITROS 5600/XT 7600 systems with the recalled calibrator kit. Those handling urine tests for sodium levels are most at risk.
Check the lot number on the calibrator kit: 277 (expired Dec 2019), 288 (expired May 2020), 298 (expired Nov 2020), or 219 (expired Jul 2021). The product code is 1662659.
Look for the lot number on the calibrator kit: 277, 288, 298, or 219.
The calibrator kit may cause inaccurate sodium results in urine tests, leading to potentially incorrect diagnoses.
This kit is used with VITROS 250/350/5,1 FS/4600/XT 3400 and VITROS 5600/XT 7600 Integrated Systems.
Check the lot number on the kit. If it matches 277, 288, 298, or 219, contact Ortho Clinical Diagnostics for instructions.
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-1226-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-1226-2020 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.
