Recall Z-1174-2007 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Dade Behring, Inc.
EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
| Date | Aug 22, 2007 (initiated Jul 3, 2007) |
| Status | Terminated |
| Reason | Sample ID and Patient results could be associated with the wrong patient |
| Root cause | Other |
| Action | The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed. |
| Quantity | 72 units |
| Distribution | Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |