Recall Z-0619-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc
Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.
| Date | Mar 6, 2003 (initiated Jan 27, 2003) |
| Status | Terminated |
| Reason | Spring failure, design defect in component. |
| Root cause | Other |
| Action | A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment) |
| Quantity | 2418 |
| Distribution | Product has been distributed in US from 8/92 to present. All these units are affected. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS Bio-Rad Laboratories, Inc., Aug 5, 1992 |