Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.
FDA device recall Z-1151-04 · posted 2004-07-23 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).
- Root cause
- Other
- Status
- Terminated
- Product code
- LEH
- Quantity affected
- 9730
- Date initiated
- 2003-04-01
- Date posted
- 2004-07-23
- Date terminated
- 2004-08-30
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SYNCHRON CONTROL (K013235) | Beckman Coulter, Inc. | 2001-10-16 |