FDA recall Z-1106-2019

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.

Distribution

The products were distributed to the following US states: WV and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2019-02-07

Report date

2019-04-17

Termination date

2020-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1106-2019