FDA Device recall Z-0970-2018
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
- FDA Device
- Class III
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class III recall of Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) by Randox Laboratories, citing the ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0970-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-08-11 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Reason
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Identifiers
| code_info | Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots:…Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979) |
|---|
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-0970-2018%22
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