Recall Z-1101-2012 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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
| Date | Feb 24, 2012 (initiated Oct 7, 2011) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984361 | ORAL-EZE ORAL FLUID COLLECTION SYSTEM Osborn Laboratories, Inc., Jan 13, 1999 |