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Open, Classified

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

FDA Recall Z-2021-2023 · Posted 2023-06-28

Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJJY
Date Initiated2023-05-04
Product Quantity1 kit

Reason for Recall

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

Firm Action

Randox issued via email to the Distributor Medical Device Correction Letter and forwarded to US and PR customers on 04 May, 2023. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the current IFU and download the updated IFU from randox.com Discuss the contents of this notice with your Medical Director. Complete and return the response for 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. If you have any questions or concerns please contact Randox Technical Services.

Root Cause

Nonconforming Material/Component

Distribution Pattern

CA, IL, VA, WA, WI including PR

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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