Recall Z-1419-2018— OraSure Technologies, Inc.
Class III · Terminated
Class III FDA medical device recall by OraSure Technologies, Inc., initiated 2017-12-20, terminated 2020-04-02. It names one FDA 510(k) clearance: K982061. Product: Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000. Reason: The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control..
- Recalling firm
- OraSure Technologies, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-12-20
- Terminated
- 2020-04-02
- 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
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Reason for recall
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Data sourced from openFDA. This site is unofficial and independent of the FDA.