Recall Z-2108-2010
International Technidyne Corporation · initiated July 8, 2010
Product
GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. 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.
Codes / lots: Part Number 0620060100 Lot # F9GC2001, Exp. 12/31/2010; and L9GC2002, Exp. 5/31/2011.
Reason for recall
Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-2108-2010
- Initiated
- July 8, 2010
- Posted by FDA
- July 28, 2010
- Terminated
- September 23, 2010
- Product code
- GGN – Plasma, Coagulation Control
- Quantity
- 101 kits
- Distribution
- 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.
- Recalling firm
- International Technidyne Corporation, Piscataway, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2107-2010 | GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk.…Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the… | 07/08/2010Terminated |