FDA Device recall Z-1106-2019
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as…
- FDA Device
- Class III
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class III recall of Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as… by Randox Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1106-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-07 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | PR, WV |
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
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.
Identifiers
| code_info | Lot codes: 1714EC 430312 432364 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1106-2019%22
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