Z-1101-2012

Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832

Name: Z-1101-2012 Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832
Creator: Capitol Vial Inc
Published: 2011-10-07
License: https://open.fda.gov/license/

Capitol Vial Inc / initiated 2011-10-07 / Terminated / root cause: design

FDA source

Capitol Vial Inc began a recall of Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse on 2011-10-07. The reason FDA records is "Low buffer fill volumes on Oral-Eze, an oral fluid collection system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1101-2012
Status: Terminated
Initiated: 2011-10-07
Posted: 2012-02-24
Terminated: 2012-08-24
Recalling firm: Capitol Vial Inc
Product: Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Low buffer fill volumes on Oral-Eze, an oral fluid collection system.
Root cause tag: design
FDA root cause: Device Design
Action: Thermo-Fisher Scientific/Capital Vial sent a Recall Notification letter dated October 7, 2011 to the sole consignee. The letter identified the affected product, problem, result impact and necessary actions to be taken. The consignee was instructed to discontinue use of the affected product and follow the necessary actions provided. If you have any questions regarding this information, call Michael Hect, Manufacturing Manager through Customer Service at (800) 772-8871.
Quantity in commerce: 135,000 units
Distribution: (USA) Nationwide Distribution - in the state of KS
Product codes and lots: Lot #, Expiration date: 07192011, exp. 04-30-2013; 07202011, exp. 04-31-2013; 07212011, exp. 04-31-2013; 07222011, exp. 05-31-2013; 07252011, exp. 05-31-2013; 07262011, exp. 05-31-2013; 07272011, exp. 05-31-2013; 07282011, exp. 05-31-2013; 07292011, exp. 05-31-2013; 07302011, exp. 05-31-2013; 07312011, exp. 05-31-2013; 08012011, exp. 05-31-2013; 08022011, exp. 05-31-2013; 08032011, exp. 05-31-2013; 08042011, exp. 05-31-2013; 08052011, exp. 05-31-2013; 08062011, exp. 05-31-2013; 08072011, exp. 05-31-2013; 08082011, exp. 05-31-2013; 08092011, exp. 05-31-2013; 08102011, exp. 05-31-2013; 08112011, exp. 05-31-2013; 08122011, exp. 05-31-2013; 08132011, exp. 05-31-2013; 08142011, exp. 05-31-2013; 08152011, exp. 05-31-2013; 08162011, exp. 05-31-2013; 08172011, exp. 05-31-2013; 08182011, exp. 05-31-2013; 08192011, exp. 05-31-2013; 08212011, exp. 05-31-2013; 08222011, exp. 05-31-2013; 08232011, exp. 05-31-2013; 08242011, exp. 05-31-2013

Product code JKA

K984361Class IIOral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. / cleared 1999-01-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)