FDA Enforcement
Class II
Ongoing
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Recall: Z-1593-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1593-2024
- Event ID
- 94138
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 24, 2024
- Initiation Date
- January 31, 2024
- Classification Date
- April 17, 2024
- Address
- 55 Diamond Road, Crumlin (North), N/A, Ireland
Description
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Reason
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Code Info
GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
Distribution
US Nationwide distribution in the states of GA, MA, WV including PR.
Quantity
8 units