Synchron LX Systems Version 4.5 Operating Software
FDA device recall Z-0009-06 · posted 2005-10-06 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- 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.
- Action taken
- Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 868
- Distribution
- Nationwide and Canada
- Date initiated
- 2005-09-06
- Date posted
- 2005-10-06
- Date terminated
- 2012-01-26
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON LX I 725 CLINICAL SYSTEM (K023049) | Beckman Coulter, Inc. | 2002-10-04 |
| MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (K011213) | Beckman Coulter, Inc. | 2001-05-16 |
| SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L (K965240) | Beckman Instruments, Inc. | 1997-03-10 |