ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy
FDA device recall Z-2221-2009 · posted 2009-09-18 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 15 units
- Distribution
- International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.
- Date initiated
- 2008-10-27
- Date posted
- 2009-09-18
- Date terminated
- 2009-12-02
- Location
- Irving, TX
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