ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20,
FDA device recall Z-2231-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.
- Action taken
- Firm notified all ARCHITECT c8000 customers with a correction letter and response form distributed on 5/23/2008. The letter provided actions the users could take until an updated software version was available. For assistance, contact Abbott at 1-877-4ABBOTT.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CGZ
- Quantity affected
- 2,378 units worldwide (431 in the USA; plus 1,947 International)
- Distribution
- Worldwide distribution, including: USA (including Puerto Rico), Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Cayman Islands, Canada, Chile, China, Colombia
- Date initiated
- 2008-05-23
- Date posted
- 2008-09-11
- Date terminated
- 2010-04-26
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |