Immunoassay Premium Plus Controls — Class III medical device recall Z-0970-2018
Terminated recall by Randox Laboratories, reported 2018-03-21, distributed nationwide. The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stabil
| Recall number | Z-0970-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Kearneysville, WV, United States |
| Recall initiated | 2017-08-11 |
| Classified | 2018-03-12 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 199 kits |
| Reason classes | specification failure |
| Lot numbers | 1476EC, 1477EDC, 1478EC, 1508EC, 1573EC, 1578EC, 1599EDC, 1619EC, 1621EC, 1647EC, 1662EC, 359199, 373302, 377412, 382147, 382679, 395668, 416979 |
| Model numbers | IA3109 |
Product
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Reason for recall
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0970-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.