ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v
FDA device recall Z-0950-2007 · posted 2007-06-19 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem
- Action taken
- Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 170 units.
- Distribution
- Worldwide distribution, including: USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, El Salvador, Germany, Guetamala, Honduras, Hong Kong, Jam
- Date initiated
- 2007-04-30
- Date posted
- 2007-06-19
- Date terminated
- 2008-03-19
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |