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.
This recall has been terminated (originally issued December 8, 2016).
- Company
- Orasure Technologies, Inc.
- Recall Initiated
- November 10, 2016
- Posted
- December 8, 2016
- Terminated
- April 17, 2017
- Recall Number
- Z-0722-2017
- Quantity
- 4 kits
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Distribution
Distributed to KS, and VA
Lot / Code Info
Lot # 6654085
Root 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
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