Recall Z-1148-03 ยท KLS Enzyme Immunoassay, Theophylline
Beckman Coulter Inc
Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29
| Date | Aug 21, 2003 (initiated Jun 18, 2003) |
| Status | Terminated |
| Reason | Defective software media distributed with upgrade software may cause installation failure and systems lock. |
| Root cause | Other |
| Action | Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media. |
| Quantity | 1615 |
| Distribution | United States only, nationwide. |
| 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 |