Alinity c CRP Vario Cardiac High Sensitivity Calibrator recall
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay…
Why was Alinity c CRP Vario Cardiac High Sensitivity Calibrator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 00681Y600
- Product
- Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay…
- Recalling firm
- Sentinel CH SpA
- Quantity
- 32
- Distribution
- US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
- Recall date
- October 13, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)