Abbott Laboratories, Inc ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Abbott Laboratories, Inc is recalling ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, due to When an ARCHITECT c16000 System is connected to an ACCELERATOR APS System, the software on the ACCELERATOR APS System may not generate an error warnin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026