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Recall Observatory FDA recall evidence

Device product

Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

Z-2021-2023

May 04, 2023

Class III

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 92344
Status
Ongoing
Classification
Class III
Quantity
1 kit
Official record key
device-enforcement:Z-2021-2023

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:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23

Distribution pattern: CA, IL, VA, WA, WI including PR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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