Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C

FDA device recall Z-2448-2023 · posted 2023-08-23 · Open, Classified

Recall details

Recalling firm

Randox Laboratories Ltd.

Reason for recall

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

Action taken

Randox Labs Ltd (Manufacturer) extended recall to the US distributor via Medical Device Correction Letter dated July 19, 2023. The distributor initial contact with customer and follow up contacts via email and telephone. Letter states reason for recall, health risk and action to take: " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com 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. If you have any questions or concerns please contact Rand ox Technical Services. Any customers using batches 590858 and 590859 for Ferritin, please contact technical.services@randox.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JIX

Quantity affected

166 units

Distribution

CA, FL, IL, ME, MI, NC, OH, PA,NJ,

Date initiated

2023-07-19

Date posted

2023-08-23

Location

Crumlin, North, Ireland

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