Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for d
FDA device recall Z-1101-2012 · posted 2012-02-24 · Terminated
Recall details
- Recalling firm
- Capitol Vial Inc
- Reason for recall
- Low buffer fill volumes on Oral-Eze, an oral fluid collection system.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 135,000 units
- Distribution
- (USA) Nationwide Distribution - in the state of KS
- Date initiated
- 2011-10-07
- Date posted
- 2012-02-24
- Date terminated
- 2012-08-24
- Location
- Auburn, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORAL-EZE ORAL FLUID COLLECTION SYSTEM (K984361) | Osborn Laboratories, Inc. | 1999-01-13 |