Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro recall
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP…
Why was Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23; 590859 28 08 23; 627222 28Jul 24; 627224 28Jul24; 634886 28Jul24; 634887 28Jul24
- Product
- Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 166 units
- Distribution
- CA, FL, IL, ME, MI, NC, OH, PA,NJ,
- Recall date
- August 30, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)