Calibration Serum with Mis-assigned Alkaline Phosphatase Target
Randox Calibration Serum Level 3 has an incorrect Alkaline Phosphatase target value (approximately 10% off) affecting clinical chemistry testing on RX Series instruments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall. This is a risk-of-harm product where a 10% calibration target error could lead to inaccurate clinical chemistry test results. No illnesses or injuries have been reported, placing this in the High category per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Randox Laboratories has recalled Calibration Serum Level 3 (Catalog Number CAL2351, Lot 1214UE, expiration date 28 November 2023). The target value for Alkaline Phosphatase (ALP) has been mis-assigned for the AMP method optimized to IFCC 37°C. The target is approximately 10% lower than the correct value.
This product is used as a calibrator in clinical chemistry assays on RX Series instruments for both quality control and patient sample testing. The mis-assigned target affects both quality control operations and patient samples analyzed on these instruments.
The affected product was distributed nationwide throughout the United States, including Puerto Rico. A total of 108 kits were distributed with lot number 1214UE and expiration date 28 November 2023. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- calibration-error
- measurement-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
Distribution
Distributed nationwide across the United States.
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