Reported Oct 13, 2021 · Terminated
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of…
Sentinel CH SpA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Sentinel CH SpA · Via Robert Koch 2 · Milan · N/A
Is this the product you have?
- Alinity c CRP Vario Cardiac High Sensitivity Calibrator
- Kit (ref 07P5605) - Product Usageuse in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer
- Lot codes and dates
- Lot 00681Y600
- Amount recalled
- 32
Where it was sold
Why it was recalled
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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