Device product
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Z-2022-2023
Product summary
- Event
- Event 92344
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 30 kits
- Official record key
device-enforcement:Z-2022-2023
Official wording
Reason: Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Code information: GTIN: 05055273203837 Batch/Lot Number: 583135 Exp. Date: 28th April 23
Distribution pattern: CA, IL, VA, WA, WI including PR
Derived failure modes
-
Unknown
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range