Reported Jun 7, 2017 · Terminated
AIA-PACK TPOAb CONTROL SET
Tosoh Bioscience, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience, Inc. · 6000 Shoreline Ct Ste 101 · South San Francisco, CA · 94080-7606
Is this the product you have?
- AIA-PACK TPOAb CONTROL SET
- Lot codes and dates
- TPOAbG644783 Expires June 2017 & G844784 Expires August 2017
- Amount recalled
- 15 boxes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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