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Terminated

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

FDA Recall Z-1106-2019 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJJY
Date Initiated2019-02-07
Date Terminated2020-06-08
Product Quantity12

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.

Firm Action

Urgent Medical Device Correction letters dated 2/7/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Randox Technical Services.

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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