FDAClass IIIApril 17, 2019

Liquid Immunoassay Premium Controls recall

Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality…

Why was Liquid Immunoassay Premium Controls recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot codes: 1723EC

Product
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality…
Recalling firm
Randox Laboratories Ltd.
Quantity
4
Distribution
The products were distributed to the following US states: WV and Puerto Rico.
Recall date
April 17, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
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