Ortho-Clinical Diagnostics recalls VITROS Cl Slides (Product Code 6844471) due to inaccurate urine chloride measurements. The slides may give false results for urine samples, potentially affecting diagnosis of electrolyte disorders.
The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.
Ortho-Clinical Diagnostics is recalling VITROS Cl Slides (Product Code 6844471) because they may give inaccurate urine chloride test results. This could lead to incorrect diagnoses of electrolyte and metabolic disorders like cystic fibrosis or diabetic acidosis.
The slides failed to meet required accuracy standards for urine chloride testing. Specifically, the lowest reliable measurement (LoQ) is 15 mmol/L instead of the claimed 5 mmol/L, which could cause false low results in urine samples.
People who use VITROS Cl Slides (Product Code 6844471) for urine chloride testing in labs or clinics are affected. Those testing urine samples for electrolyte disorders are most at risk of incorrect diagnoses.
Check for VITROS Cl Slides with Product Code 6844471. These slides are used with VITROS 250/350/5,1 FS, 4600 Chemistry Systems, and VITROS 5600 Integrated Systems for urine chloride testing.
Look for Product Code 6844471 on the slides to confirm if they are recalled.
The slides failed to meet required accuracy standards for urine chloride testing, specifically giving false low results when the lowest reliable measurement (LoQ) is 15 mmol/L instead of the claimed 5 mmol/L.
The recall does not require stopping use immediately; however, users should check if they have the recalled product code and consider alternative testing methods if accuracy is critical.
Check the product code on the slides. If it is 6844471, contact Ortho-Clinical Diagnostics for guidance on alternative testing options.
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-3184-2018 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-3184-2018 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.
