International Medical Devices Database

Manufacturer Address
Perkin Elmer Life and Analytical Sciences Inc, 3985 Eastern Rd, Norton OH 44203-6215
Source
USFDA
2 Events
- Recall of Device Recall GAO, Neonatal Total Galactose Test Kit
- Recall of Device Recall GAO, Neonatal Total Galactose Test Kit

2 devices in the database

Device Recall GAO, Neonatal Total Galactose Test Kit

Model / Serial
Lots #178052, Exp 2/7/04; #182567, Exp 1/7/04; #195339, Exp 2/18/04; #207487, Exp 4/29/04.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
The kits were shipped to domestic end-users located in NJ, PA, TX, IN, MI, MO, IL, CO, CT, AR, FL, LA, OH, NM, WA.
Product Description
Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000

Device Recall GAO, Neonatal Total Galactose Test Kit

Model / Serial
Lots #177835, Exp 1/7/04; #178068, Exp 2/7/04; #195324, Exp 2/18/04; #204423, Exp 4/8/04; #207440, Exp 4/29/04; #213466, Exp 5/24/04.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
The kits were shipped to domestic end-users located in NJ, PA, TX, IN, MI, MO, IL, CO, CT, AR, FL, LA, OH, NM, WA.
Product Description
Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000

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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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Perkin Elmer Life and Analytical Sciences Inc

2 devices in the database

Device Recall GAO, Neonatal Total Galactose Test Kit

Device Recall GAO, Neonatal Total Galactose Test Kit