Tosoh AIA-PACK TPOAb Control Set Recalled for Labeling Errors
Tosoh Bioscience is recalling 15 boxes of AIA-PACK TPOAb Control Sets 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 duplicate instructions, fitting the criteria for a Low severity score.
Plain-English summary
Tosoh Bioscience, Inc. is recalling 15 boxes of AIA-PACK TPOAb Control Sets. 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 Alaska, Florida, Georgia, Massachusetts, New York, Ohio, Oklahoma, and Texas. The specific lot codes involved are TPOAb G644783 (Expires June 2017) and G844784 (Expires August 2017).
Consumers and healthcare facilities should stop using the affected control sets and contact Tosoh Bioscience, Inc. for further instructions or a refund.
The recalled product
- Product
- AIA-PACK TPOAb CONTROL SET
- Manufacturer
- Tosoh Bioscience, Inc.
- Hazard
- Affected units
- 15
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 (1)
- TPOAb: G644783 Expires June 2017 & G844784 Expires August 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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