Recall Z-0009-06 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc
Synchron LX Systems Version 4.5 Operating Software
| Date | Oct 6, 2005 (initiated Sep 6, 2005) |
| Status | Terminated |
| Reason | Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit. |
| Root cause | Software design |
| Action | Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter. |
| Quantity | 868 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011213 | MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM Beckman Coulter, Inc., May 16, 2001 |
| K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc., Oct 4, 2002 |
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc., Mar 10, 1997 |