Ortho-Clinical Diagnostics Recalls VITROS Signal Reagent Due to Labeling Defects
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Signal Reagent, Lot 3082, because the reagent packs may contain blank labels.
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 packaging/labeling defect (blank labels) without reported injuries or illnesses.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360. The recall involves Lot 3082, which has an expiry date of 7/27/2015. The product is supplied as a sales unit box containing two Signal Reagent Packs.
The recall was initiated because the reagent packs may contain blank labels. Labels are required to include the name of the reagent, a barcode, lot information, and expiry dating. The recall covers 898 units distributed nationwide.
Users of this product should stop using the affected reagent packs and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is…
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Hazard
- Affected units
- 898
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 3082
- expiry date 7/27/2015
Distribution
Distributed nationwide across the United States.
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