Device product
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.
Z-0660-2019
Product summary
- Event
- Event 81664
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 kits (32 kits US / 218 kits OUS)
- Official record key
device-enforcement:Z-0660-2019
Official wording
Reason: 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.
Code information: 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Distribution pattern: US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
Derived failure modes
-
Unknown
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.