Immunoassay Premium Plus Controls — Class III medical device recall Z-1106-2019
Terminated recall by Randox Laboratories Ltd., reported 2019-04-17, distributed in PR, WV. The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyze
| Recall number | Z-1106-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2019-02-07 |
| Classified | 2019-04-08 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-06-08 |
| Distributed | PR, WV |
| Quantity | 12 |
| Lot numbers | 1714EC, 430312, 432364 |
| Model numbers | IA3109, IA3112 |
Product
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Reason for recall
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
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-1106-2019. 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.