OraSure Cocaine Test Kit May Give False Positives - Recall
OraSure Technologies recalls cocaine metabolite test kits that may cause false positive results with negative controls. Affected units include specific catalog numbers and expiration dates.
Lower-risk recall
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Contact the company
What happened, in plain English
OraSure's Cocaine Metabolite MICRO-PLATE EIA test kits may give false positive results due to issues with controls and calibrators. This could lead to incorrect drug test outcomes, especially if used for workplace or legal testing. Read more at govinfonow.com/recall/72261-orasure-cocaine-test-kit-may-give-false-positives-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/72261-orasure-cocaine-test-kit-may-give-false-positives-recall · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1419-2018
Cite this page
“OraSure Cocaine Test Kit May Give False Positives - Recall.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72261-orasure-cocaine-test-kit-may-give-false-positives-recall. Based on FDA recall #Z-1419-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1419-2018%22&limit=1).
Why it’s dangerous
The test kit's controls and calibrators can produce false positive results when used with the negative control. This means the test might incorrectly indicate cocaine presence when it's not actually there, potentially causing unnecessary concern or actions.
Who’s affected
Users of the Cocaine Metabolite MICRO-PLATE EIA test kits with the specified catalog number and expiration date are affected. People relying on these kits for drug testing may face inaccurate results.
How to tell if you have this one
Check for the catalog number 1122SC and expiration date 02/28/2018 on the test kit. The unique device identifier (UDI) is (0100608337000429(17)180228(10)000).
- Brand
OraSure- Category
Medical device
What to do — step by step
Check Kit Details
Verify the catalog number 1122SC and expiration date 02/28/2018 on the test kit.
Where it went and when
Where it was distributed
Distributed in Kansas.
FDA distribution: “Distributed to 2 consignees in KS.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kansas.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1419-2018 (December 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1419-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 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.