ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
FDA Recall Z-2221-2009 · Posted 2009-09-18
Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2008-10-27
Date Terminated2009-12-02
Product Quantity15 units
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.
Firm Action
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
Distribution Pattern
International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.