Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc.
FDA device recall Z-1350-2008 · posted 2008-03-27 · Terminated
Recall details
- Recalling firm
- Wescor, Inc
- Reason for recall
- Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
- Action taken
- Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJM
- Quantity affected
- 950 vials
- Distribution
- Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Paraguay, Poland, Singapore, South Afri
- Date initiated
- 2007-12-26
- Date posted
- 2008-03-27
- Date terminated
- 2008-03-27
- Location
- Logan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLLOID OSMOMETER 4400 (K834208) | Wescor, Inc. | 1984-03-23 |