OraSure Recalls OraQuick HCV Visual Reference Panel Due to Incorrect Insert
OraSure Technologies is recalling 244 OraQuick HCV Visual Reference Panel kits because the package insert may be incorrect, potentially containing instructions for a different test.
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: This is an FDA Class III recall involving a documentation error (incorrect package insert) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
OraSure Technologies, Inc. is recalling 244 kits of the OraQuick HCV Visual Reference Panel. The recall was initiated after the company received a customer complaint indicating that the package insert included with the product may be incorrect.
The customer reported receiving the Ora Quick Ebola Visual Reference Panel instead of the intended OraQuick HCV Visual Reference Panel. The product is intended to assist new operations in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
The affected product is identified by Item Number 1001-0343 and Lot # 6648737. The kits were distributed nationwide to specific states including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI. Consumers and healthcare facilities should check their inventory for this specific lot number and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
- Manufacturer
- OraSure Technologies, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 244
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)
- Item Number 1001-0343
- Lot # 6648737
Distribution
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