Recall Z-0722-2017
OraSure Technologies, Inc. · initiated November 10, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Lot # 6654085
Reason for recall
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
FDA-determined cause: Mixed-up of materials/components
Action taken
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
Details
- Recall number
- Z-0722-2017
- Initiated
- November 10, 2016
- Posted by FDA
- December 8, 2016
- Terminated
- April 17, 2017
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Quantity
- 4 kits
- Distribution
- Distributed to KS, and VA
- Recalling firm
- OraSure Technologies, Inc., Bethlehem, PA