Z-2221-2009

ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate...

Name: Z-2221-2009 ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate...
Creator: Abbott Laboratories, Inc
Published: 2008-10-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-10-27 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy on 2008-10-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2221-2009
Status: Terminated
Initiated: 2008-10-27
Posted: 2009-09-18
Terminated: 2009-12-02
Recalling firm: Abbott Medical
Product: ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 15 units
Distribution: International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.
Product codes and 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.

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)