Devices

Device Recall Neonatal GALT Test Kit

Model / Serial
Lot #115496, Exp. 11/1/03
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
The kits were shipped to three (3) State Departments of Health in WI, AR, and MI.
Product Description
Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
Manufacturer
PerkinElmer LIfe Sciences Inc
1 Event
- Recall of Device Recall Neonatal GALT Test Kit

Manufacturer

PerkinElmer LIfe Sciences Inc

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

One device with a similar name

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Device Recall Neonatal GALT Test Kit

Model / Serial
Lot #164738
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
Product Description
Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
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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