Z-1350-2008

Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for...

Name: Z-1350-2008 Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for...
Creator: Wescor, Inc
Published: 2007-12-26
License: https://open.fda.gov/license/

ELITechGroup Inc / initiated 2007-12-26 / Terminated / root cause: manufacturing process

FDA source

Wescor, Inc began a recall of Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah... on 2007-12-26. The reason FDA records is "Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1350-2008
Status: Terminated
Initiated: 2007-12-26
Posted: 2008-03-27
Terminated: 2008-03-27
Recalling firm: ELITechGroup Inc
Product: 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.
Product code: JJM Osmometer For Clinical Use
Reason for recall: Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 6 units packages: 0256118, 0256131, 0256151, 0256195, 0256213, 0256248, 0256306, 0256354, 0257016, 0257113, 0257032, 0257071, 0257150, 100299, 100500, 100677, and 100183: Individual vials Lot Numbers: I-61-22 , expiration 4/08 and I-62-34, expiration 10/08; Only individual vials of SS-025 (Lot I-62-34, expiration 10/08 ) included in Osmocoll SS-039 of 6 unit package Lot Numbers: 0397032 and 100455.

Product code JJM

K834208Class IColloid Osmometer 4400Wescor, Inc. / cleared 1984-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)