Date Initiated by Firm | September 11, 2009 |
Date Posted | April 09, 2010 |
Recall Status1 |
Terminated 3 on January 25, 2011 |
Recall Number | Z-1316-2010 |
Recall Event ID |
53479 |
510(K)Number | K983212 |
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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Product | ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01.
The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology. |
Code Information |
List numbers 5F48-22 and 5F48-23, part numbers 7-204717-01 and 7-204717-02 when used with 7-94255-01 and 7-200788-01. |
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 | ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters. |
FDA Determined Cause 2 | Software design |
Action | Technical Service Bulletins dated September 11, 2009 were issued to affected consignees. The correction was issued via the Technical Service Bulletins (TSB) to provide a software patch to re-establish the correct parameters on the LLS board. Direct questions to Abbott Laboratories, Inc. by calling 1-972-518-6000. |
Quantity in Commerce | 11 in the USA; 104 worldwide |
Distribution | Worldwide. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = JJE
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