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
FDA device recall Z-1316-2010 · posted 2010-04-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 11 in the USA; 104 worldwide
- Distribution
- Worldwide.
- Date initiated
- 2009-09-11
- Date posted
- 2010-04-09
- Date terminated
- 2011-01-25
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |