Recall Z-0660-2019— Randox Laboratories Ltd.
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2018-11-19, terminated 2020-04-23. It names one FDA 510(k) clearance: K031608. 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.. 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..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-19
- Terminated
- 2020-04-23
- Firm location
- Crumlin (North), Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.