Wescor, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Wescor, Inc
Lot Codes / Batch Numbers
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)
Products Sold
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)
Wescor, Inc is recalling Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and due to Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
Recommended Action
Per FDA guidance
Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026