Recall Z-0398-06 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX.
| Date | Jan 18, 2006 (initiated Dec 8, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Firm initiated recall to all consignees via letter dated 12/08/05. |
| Quantity | 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, SC, SD, TN, TX, UT, VA, WA, WI and WY. Foreign distribution to the following countries: Argentin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |