ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
This recall has been terminated (originally issued September 18, 2009).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- October 27, 2008
- Posted
- September 18, 2009
- Terminated
- December 2, 2009
- Recall Number
- Z-2221-2009
- Quantity
- 15 units
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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.
Distribution
International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.
Lot / Code Info
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.
Root 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.