Devices

Device Recall ELaCL AntiCardiolipin ELISA Kit

Model / Serial
catalog #201-204: kit lot 09055514, exp. 14-JUL-2006, serum diluent lot 09055546, exp 04-OCT-2006; and kit lot 12055603, exp. 09-NOV-2006, serum diluent lot 11055595, exp. 18-NOV-2007
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida.
Product Description
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148
Manufacturer
Thera Test Laboratories, Inc.
1 Event
- Recall of Device Recall ELaCL AntiCardiolipin ELISA Kit

Manufacturer

Thera Test Laboratories, Inc.

Manufacturer Address
Thera Test Laboratories, Inc., 1111 N Main St, Lombard IL 60148-1360
Source
USFDA

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