Recall Z-0033-2022 ยท JIS Calibrator, Primary
Sentinel CH SpA
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
| Date | Jul 29, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Firm notified distributor July 29, 2021, and provided an Urgent Field Safety Notice letter to be forwarded to final end users on August 20, 2021. Customers were advised to do the following: - Immediately discontinue use of affected lot of calibrator - Destroy any remaining inventory of affected lot according to your laboratory procedures - Contact Abbott to order replacement material - Review the content of the communication with your Medical Director - Retain the letter for future reference Please forward notification to all individuals in your organization who need to be aware, or to any |
| Quantity | 32 |
| Distribution | US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.