OraSure Cocaine Metabolite Test Kit Recalled for False Positive Results
OraSure Technologies is recalling 10 units of Cocaine Metabolite MICRO-PLATE EIA kits because controls may cause false positive results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
OraSure Technologies, Inc. is recalling 10 units of the Cocaine Metabolite MICRO-PLATE EIA, Catalog Number 1122SC. The affected product is identified by Lot Number 0006661251 and has an expiration date of 02/28/2018. The recall is classified as Class III by the U.S. Food and Drug Administration.
The recall was initiated because the controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control. This issue could lead to inaccurate test outcomes.
The product was distributed to 2 consignees in Kansas. Users of the affected kits should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
- Manufacturer
- OraSure Technologies, Inc.
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 0006661251
- Expiration date: 02/28/2018
Distribution
Distributed in 1 state:
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