SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
FDA device recall Z-0886-06 · posted 2006-05-18 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.
- Action taken
- A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)
- Root cause
- Other
- Status
- Terminated
- Product code
- LEH
- Quantity affected
- 3147
- Distribution
- Nationwide & Canada
- Date initiated
- 2006-03-30
- Date posted
- 2006-05-18
- Date terminated
- 2012-02-29
- 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 SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR (K013076) | Beckman Coulter, Inc. | 2001-12-12 |