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.
FDA Recall Z-1350-2008 · Posted 2008-03-27
Recalling FirmWescor, Inc
Recall StatusTerminated
Product CodeJJM
Date Initiated2007-12-26
Date Terminated2008-03-27
Product Quantity950 vials
Reason for Recall
Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.