FDA Medical Device Recalls (openFDA)
Capitol Vial Inc: Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse
- Recall number
- Z-1101-2012
- 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
- Status
- Terminated
- Initiated
- 2011-10-07
- Posted
- 2012-02-24
- Terminated
- 2012-08-24
- Reason
- Low buffer fill volumes on Oral-Eze, an oral fluid collection system.
- 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
- 135,000 units
- Distribution
- (USA) Nationwide Distribution - in the state of KS
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K984361"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3000325731
- Firm city
- Auburn
- Firm state
- AL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28