Recall Z-2221-2009
Abbott Laboratories, Inc · initiated October 27, 2008
Product
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
Codes / lots: Serial Numbers: ABT 042, ABT 055, ABT 037, ABT 016, ABT 041, ABT 046, ABT 035, ABT 040, ABT 039, ABT 033, ABT 028, ABT 011, ABT 006 and ABT 007.
Reason for recall
When an ARCHITECT c16000 System is connected to an ACCELERATOR APS System, the software on the ACCELERATOR APS System may not generate an error warning when a Sample Presentation/Sample Queue error occurs, which could result in contamination of subsequent samples.
FDA-determined cause: Software design
Action taken
Abbott Laboratories notified Customers of the affected device via a "Product Correction" letter dated October 27, 2008. Consignees provided with a temporary work around until a service representative upgrades the system software. For further information, contact your local Abbott Laboratories, Inc. service representative.
Details
- Recall number
- Z-2221-2009
- Initiated
- October 27, 2008
- Posted by FDA
- September 18, 2009
- Terminated
- December 2, 2009
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 15 units
- Distribution
- International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX