ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, T
FDA device recall Z-0398-06 · posted 2006-01-18 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.
- Action taken
- Firm initiated recall to all consignees via letter dated 12/08/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1206 units.
- Distribution
- Worldwide. Product distributed nationwide to direct accounts (including gov''t accounts) in: AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA,
- Date initiated
- 2005-12-08
- Date posted
- 2006-01-18
- Date terminated
- 2007-09-25
- 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 |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |