Recall Z-0843-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
Aeroset Analyzer, item 9D05-01
| Date | May 20, 2003 (initiated Oct 2, 2001) |
| Status | Terminated |
| Reason | Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule. |
| Root cause | Other |
| Action | The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system. |
| Quantity | 238 units |
| Distribution | Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |