FDA Device recall Z-0660-2019
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, I…
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, I… by Randox Laboratories, citing 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 cor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0660-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-19 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | IN, NJ, NY, TX, WV |
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.
Identifiers
| code_info | 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0660-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.