Devices

Device Recall ST AIAPACK PROG III

Model / Serial
All lots
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
Product Description
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Manufacturer
Tosoh Bioscience Inc
1 Event
- Recall of Device Recall ST AIAPACK PROG III

Manufacturer

Tosoh Bioscience Inc

Manufacturer Address
Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
Manufacturer Parent Company (2017)
Tosoh Corp.
Source
USFDA

One device with a similar name

Learn more about the data here

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.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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