Recall Z-1153-04 ยท JIS Calibrator, Primary
Beckman Coulter Inc
Synchron Systems Lipid Calibrator (HDLD) Part 650218
| Date | Jul 23, 2004 (initiated Oct 3, 2003) |
| Status | Terminated |
| Reason | Incorrect units are printed in labeling but not in software. |
| Root cause | Other |
| Action | Letter was mailed which explains tha the units on the Value Sheet are printed incorrectly. Recall is complete. |
| Quantity | 2069 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983640 | SYNCHRON SYSTEMS LIPID CALIBRATOR Beckman Coulter, Inc., Dec 21, 1998 |