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Recall Observatory FDA recall evidence

Device 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

Z-1106-2019

February 07, 2019

Class III

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 82184
Status
Terminated
Classification
Class III
Quantity
12
Official record key
device-enforcement:Z-1106-2019

Official wording

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.

Code information: Lot codes: 1714EC 430312 432364

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.