OraSure Barbiturate Micro-Plate EIA Recalled for Shipping Error
OraSure Technologies is recalling four kits of Barbiturates Intercept Micro-Plate EIA because cocaine metabolite microplates were shipped instead.
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 by definition is unlikely to cause adverse health consequences. The issue is a shipping error involving the wrong product type rather than a safety defect in the product itself.
Plain-English summary
OraSure Technologies, Inc. is recalling four kits of the Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate). The product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
The recall was initiated due to a shipping error. During manufacturing, the incorrect microplate was selected, resulting in the distribution of cocaine metabolite microplates instead of the intended barbiturate microplates.
The affected product, identified by Lot # 6654085, was distributed to Kansas and Virginia. Clinical laboratories should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
- Manufacturer
- OraSure Technologies, Inc.
- Hazard
- Affected units
- 4
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 (1)
- Lot # 6654085
Distribution
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