Recall Z-0722-2017— OraSure Technologies, Inc.
Class III · Terminated
Class III FDA medical device recall by OraSure Technologies, Inc., initiated 2016-11-10, terminated 2017-04-17. It names one FDA 510(k) clearance: K001976. 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.. Reason: Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing..
- Recalling firm
- OraSure Technologies, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-11-10
- Terminated
- 2017-04-17
- Firm location
- Bethlehem, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.