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U.S. Department of Health and Human Services

Class 2 Device Recall ACCELERATOR Automated Processing System

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  Class 2 Device Recall ACCELERATOR Automated Processing System see related information
Date Initiated by Firm October 27, 2008
Date Posted September 18, 2009
Recall Status1 Terminated 3 on December 02, 2009
Recall Number Z-2221-2009
Recall Event ID 50488
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
Code Information 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.
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038-4313
For Additional Information Contact
972-518-6000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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