Sentinel CH SpA recalls

2 official recalls and safety alerts involving Sentinel CH SpA since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Sentinel CH SpA or the relevant agency.

1. 2023-11-29
2. US
   Drugs & medicalClass II

   Sentinel CH SpA recalls IRON assay, Reference Numbers 6K95-41 and 6K95-30

   A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent…

   FDA · DeviceSentinel CH SpAWorldwide - US Nationwide distribution.Official notice →
3. 2021-10-13
4. US
   Drugs & medicalClass III

   Sentinel CH SpA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP…

   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.

   FDA · DeviceSentinel CH SpAUS Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto…Official notice →