Food, drugs, devices › OraSure Technologies, Inc.
Device recall: Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C
FDA enforcement event 87340 is a device recall by OraSure Technologies, Inc. of Bethlehem, PA, initiated 5 Feb 2021 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 3% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 30 Mar 2023. Initiation: voluntary: firm initiated. OraSure Technologies, Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
OraSure Technologies, Inc., Bethlehem, PA.
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."
Distribution
"US Nationwide distribution in the states of KS, NJ, OH, VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1183-2021 | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. | 16 units | Class III | Terminated | 17 Mar 2021 |
Context
Other enforcement events for OraSure Technologies, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Jul 2020 | CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical | Device | Class III | 3 |
| 13 Jul 2020 | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Im | Device | Class III | 2 |
| 20 Dec 2017 | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 | Device | Class III | 1 |
| 10 Nov 2016 | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laborat | Device | Class III | 1 |
| 20 Jul 2016 | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola | Device | Class I | 1 |
| 15 Jan 2016 | OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with an | Device | Class III | 1 |
All 7 events for OraSure Technologies, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of KS, NJ, OH, VA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Mar 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.