Recall Z-0008-06 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
| Date | Oct 6, 2005 (initiated Feb 28, 2005) |
| Status | Terminated |
| Reason | Device has incorrect notation associated with therapeutic drug monitoring assays. |
| Root cause | Other |
| Action | Firm sent device correction letters to consignees on 2/28/2005. |
| Quantity | 1,107 units worldwide |
| Distribution | California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |