Reported May 5, 2021 · Terminated
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, INc. · 513 Technology Blvd · Rochester, NY · 14626-3601
Is this the product you have?
- VITROS¿ Black Reference Slides CATALOG #:
- J02316 - Product UsageThe Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure
- Lot codes and dates
- Lots
9252-0058-33619252-0058-3362
- Lots
- Amount recalled
- 865 units of 25 slides each
Where it was sold
Why it was recalled
Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
This product could cause temporary or reversible health problems — stop using it.
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