Devices

Device Recall Neonatal Total Galactose Test Kit

Model / Serial
Lots: #112770, Exp 6/14/03; and #116017, Exp 7/4/03.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.
Product Description
Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays.
Manufacturer
PerkinElmer Life Sciences Inc
1 Event
- Recall of Device Recall Neonatal Total Galactose Test Kit

Manufacturer

PerkinElmer Life Sciences Inc

Manufacturer Address
PerkinElmer Life Sciences Inc, 3985 Eastern Rd, Norton OH 44203
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Neonatal Total Galactose Test Kit

Model / Serial
Lots: #112785, Exp 6/14/03; and #116002, Exp 7/4/03.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.
Product Description
Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
Manufacturer
PerkinElmer Life Sciences Inc

Device Recall Neonatal Total Galactose Test Kit

Model / Serial
Lot #116020, Exp 7/4/03.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.
Product Description
Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.
Manufacturer
PerkinElmer Life Sciences Inc

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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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