Devices

Device Recall ST AIAPACK PROG III Calibrator Set

Model / Serial
Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Product Description
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
Tosoh Bioscience, Inc.
1 Event
- Recall of Device Recall ST AIAPACK PROG III Calibrator Set

Manufacturer

Tosoh Bioscience, Inc.

Manufacturer Address
Tosoh Bioscience, Inc., 6000 Shoreline Ct Ste 101, South San Francisco CA 94080-7606
Manufacturer Parent Company (2017)
Tosoh Corp.
Source
USFDA

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