Recall Z-1183-2021— OraSure Technologies, Inc.
Class III · Terminated
Class III FDA medical device recall by OraSure Technologies, Inc., initiated 2021-02-05, terminated 2023-03-30. It names one FDA 510(k) clearance: K993208. Product: Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.. Reason: Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance..
- Recalling firm
- OraSure Technologies, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-02-05
- Terminated
- 2023-03-30
- 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
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Reason for recall
Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.