Z-0660-2019 Class II Terminated
FDA device recall Z-0660-2019 was initiated by Randox Laboratories Ltd. on Nov 19, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 23, 2020). Affected quantity: 250 kits (32 kits US / 218 kits OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 2, 2019
- Initiation Date
- Nov 19, 2018
- Termination Date
- Apr 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 kits (32 kits US / 218 kits OUS)
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.
Distribution Pattern
US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
Code Information
05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0660-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026