GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
Recall
- Recall Number
- Z-2107-2010
- Event Number
- 56169
- Firm
- International Technidyne Corporation
- FEI Number
- 3005776351
- Product Code
- GGN
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- July 8, 2010
- Posted
- July 28, 2010
- Terminated
- September 23, 2010
- Address
- 20 Corporate Pl S, Piscataway, NJ, 08854-6144
Description
GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
Urgent: Medical Device Correction Notices, dated July 1, 2010, were sent by Federal Express on July 8, 2010 to all first consignee end users. The letters identified the affected product and asked customers to review and follow all instructions as outlined in the ITC in the communication. The info should be shared with laboratory staff and the notification should be retained as part of the laboratory Quality System documentation. The enclosed response form should be completed and returned to ITC within 5 days.
Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
95 kits C9GC5001; 32 kits G9GC5003; 46 kits J9GC5004; 5 kits C0GC5001; Each kit contains 15 vials.