SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Reported: January 2, 2019 Initiated: November 19, 2018 #Z-0660-2019
Product Description
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Reason for Recall
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 250 kits (32 kits US / 218 kits OUS)
- Distribution
- US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
- Location
- Crumlin (North)
Frequently Asked Questions
What product was recalled? ▼
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.. Recalled by Randox Laboratories Ltd.. Units affected: 250 kits (32 kits US / 218 kits OUS).
Why was this product recalled? ▼
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0660-2019.
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