FDA-Device2016-08-03Class III
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.
Tosoh Bioscience, Inc.
Hazard
Instructions For Use had incorrect lot number and calibrator values
Sold states
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Affected count
41 single sets of Progesterone 3 calibrators
Manufactured in
6000 Shoreline Ct Ste 101, N/A, South San Francisco, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2282-2016Don't want to check this manually?
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