Recall Z-0722-2017 ยท DIS Enzyme Immunoassay, Barbiturate
OraSure Technologies, Inc.
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
| Date | Dec 8, 2016 (initiated Nov 10, 2016) |
| Status | Terminated |
| Reason | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing. |
| Root cause | Mixed-up of materials/components |
| Action | Due to the small number of customers that were affected by the recall, OraSure notified customers on November 10, 2016, via telephone with a follow-up email. Customers were asked to quarantine the units on hand and they will schedule a pickup by Fed EX to retrieve the affected units. For further questions, please call (610) 882-1820, ext. 1657 |
| Quantity | 4 kits |
| Distribution | Distributed to KS, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I OraSure Technologies, Inc., Dec 6, 2000 |