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Devices
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
Manufacturer
Perkin Elmer Life and Analytical Sciences Inc
1 Event
Recall of Device Recall GAO, Neonatal Total Galactose Test Kit
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Manufacturer
Perkin Elmer Life and Analytical Sciences Inc
Manufacturer Address
Perkin Elmer Life and Analytical Sciences Inc, 3985 Eastern Rd, Norton OH 44203-6215
Source
USFDA
One device with a similar name
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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
Manufacturer
Perkin Elmer Life and Analytical Sciences Inc
Language
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