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Open, Classified

Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

FDA Recall Z-2609-2023 · Posted 2023-09-19

Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJJY
Date Initiated2023-08-03
Product Quantity66 kits

Reason for Recall

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Firm Action

A Medical Device Correction notification letter dated 8/3/23 was sent to customers. Action to be taken: " Review Quality Control data generated using the affected lot. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 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 organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns please contact Randox Technical Services.

Root Cause

Under Investigation by firm

Distribution Pattern

US States: GA, OH, OR, PA, TX, VA

Official Source

View FDA Recall →

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

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