Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Reported: April 24, 2024 Initiated: January 31, 2024 #Z-1593-2024
Product Description
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Reason for Recall
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%.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 8 units
- Distribution
- US Nationwide distribution in the states of GA, MA, WV including PR.
- Location
- Crumlin (North)
Frequently Asked Questions
What product was recalled? ▼
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567. Recalled by Randox Laboratories Ltd.. Units affected: 8 units.
Why was this product recalled? ▼
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%.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1593-2024.
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