Tosoh Bioscience Recalls AIA-PACK TgAb Control Set Due to Labeling Error
Tosoh Bioscience is recalling 64 boxes of AIA-PACK TgAb Control Set because the labels included instructions for a non-FDA approved methodology.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a labeling error involving instructions, not a direct physical hazard or contamination.
Plain-English summary
Tosoh Bioscience, Inc. is recalling 64 boxes of the AIA-PACK TgAb Control Set. The recall was initiated because the product labels contained two different methodologies. Specifically, the labels included Quality Control values for a non-FDA approved methodology (CL) in addition to the values for the FDA approved methodology (AIA). Two sets of instructions were included on the label.
The affected product was shipped to the following states: AK, FL, GA, MA, NY, OH, OK, and TX. The specific lot codes involved are TgAb: G644899 (Expires June 2017), G844801 (Expires August 2017), and GX44802 (Expires 09/30/2017).
Consumers and healthcare facilities should stop using the affected product and contact Tosoh Bioscience, Inc. for instructions on return or replacement.
The recalled product
- Product
- AIA-PACK TgAb CONTROL SET
- Manufacturer
- Tosoh Bioscience, Inc.
- Hazard
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- TgAb: G644899 Expires June 2017
- G844801 Expires August 2017 & GX44802 Expires 09/30/2017.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Tosoh Bioscience, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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