Recall Z-1351-2008
Wescor, Inc · initiated December 26, 2007
Product
Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
Codes / lots: Lot Numbers: 100136, 100445, and 100558; Individual vials Lot Numbers: I-65-18, expiration 9/09 (low control) and I-65-19, expiration 7/09 (high control)
Reason for recall
Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
FDA-determined cause: Nonconforming Material/Component
Action taken
Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.
Details
- Recall number
- Z-1351-2008
- Initiated
- December 26, 2007
- Posted by FDA
- March 27, 2008
- Terminated
- March 27, 2008
- Product code
- JJM – Osmometer For Clinical Use
- Quantity
- 75 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 Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom.
- Recalling firm
- Wescor, Inc, Logan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1350-2008 | Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials…Inaccurate readings; The control does not provide an accurate calibration value/readings when performing… | 12/26/2007Terminated |