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Tosoh Bioscience, Inc. recalls Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for
Recalled August 3, 2016 · FDA recall Z-2282-2016 · Tosoh Bioscience
Hazard
Instructions For Use had incorrect lot number and calibrator values · FDA Class III
Units
41 single sets of Progesterone 3 calibrators
Sold at
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Description
Instructions For Use had incorrect lot number and calibrator values
Product
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Manufacturer(s)
Tosoh Bioscience, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →