Recall Z-2231-2008 ยท CGZ Electrode, Ion-Specific, Chloride
Abbott Laboratories, Inc
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement)
| Date | Sep 11, 2008 (initiated May 23, 2008) |
| Status | Terminated |
| Reason | Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |