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.
FDA Recall Z-0722-2017 · Posted 2016-12-08
Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeDIS
Date Initiated2016-11-10
Date Terminated2017-04-17
Product Quantity4 kits
Reason for Recall
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Firm 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
Root Cause
Mixed-up of materials/components
Distribution Pattern
Distributed to KS, and VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.