Recall Z-1350-2008 ยท JJM Osmometer For Clinical Use
Wescor, Inc
Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
| Date | Mar 27, 2008 (initiated Dec 26, 2007) |
| Status | Terminated |
| Reason | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product. |
| Quantity | 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 Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834208 | COLLOID OSMOMETER 4400 Wescor, Inc., Mar 23, 1984 |