FDAClass IIIJune 7, 2017

Aia-pack Tgab Control SET recall

AIA-PACK TgAb CONTROL SET

Why was Aia-pack Tgab Control SET recalled?

The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

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?

TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.

Product
AIA-PACK TgAb CONTROL SET
Recalling firm
Tosoh Bioscience, Inc.
Quantity
64 boxes
Distribution
Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
Recall date
June 7, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls