FDA-Device2017-06-07Class III
AIA-PACK TPOAb CONTROL SET
Tosoh Bioscience, Inc.
Hazard
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.
Sold states
Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
Affected count
15 boxes
Manufactured in
6000 Shoreline Ct Ste 101, South San Francisco, CA, United States
Products
AIA-PACK TPOAb CONTROL SET
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2168-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief