Lower riskMedical device recall · FDA · Published February 5, 2021
OraSure Methamphetamine Intercept Kit Recall: Incorrect Reagent Lot Risk
OraSure recalls Methamphetamine Intercept Microplate kits with incorrect reagent lot numbers. This may affect test accuracy but does not cause injury. Consumers should check their kit's lot number and contact OraSure for details.
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.
Take action
Contact the company
📍Recalling firmOraSure Technologies, Inc.220 E 1st St · Bethlehem, PA 18015-1360
“OraSure Methamphetamine Intercept Kit Recall: Incorrect Reagent Lot Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63302-orasure-methamphetamine-intercept-kit-recall-incorrect-reagent-lot-risk. Based on FDA recall #Z-1183-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1183-2021%22&limit=1).
The FDA announced on Feb. 5, 2021, that OraSure Technologies Inc. voluntarily recalled the Methamphetamine Intercept Microplate kit EIA due to a labeling error involving the Substrate Reagent lot. The agency classified the recall as Class III.
The original kit box labeling and specification sheet listed Substrate Reagent (TMB) lot 6676239, but the kit contained lot 6679623. The record states this discrepancy should not affect performance.
Context
GovInfoNow's records show OraSure Technologies Inc. has issued three other recalls since Dec. 20, 2017. Other recent recalls of similar products include the Immunotech Estrone RIA Kit Recall (Dec. 15, 2025), Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), and Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check the kit's lot number on the box, which should be 6681090 for this recall. The expiration date is March 2021. The unique device identifier (UDI) is 608337000191.
Brand
OraSure
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for lot number 6681090 on the kit box. If it matches, the kit is affected.
Contact OraSure
Reach out to OraSure Technologies for further guidance on the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of KS, NJ, OH, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Kansas, New Jersey, Ohio, Virginia.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1183-2021 (February 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1183-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.