BD Biosciences Recalls Contaminated CD8 PE In Vitro Diagnostic Reagent
BD Biosciences is recalling one lot of CD8 PE reagent contaminated with CD4 FITC, which may cause incorrect patient data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (incorrect patient data) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
BD Biosciences, Systems & Reagents is recalling one lot of CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. The product is a hematology reagent used for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes. The recall involves 165 units of Lot number 4220622, with an expiry date of 2016-04-30.
The recall was initiated because the product is contaminated with CD4 FITC. This contamination may cause an unexpected staining pattern and incorrect patient data. The product was distributed worldwide, including in the United States (nationwide including Puerto Rico), China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile, and Malaysia.
Healthcare facilities and laboratories should stop using the affected lot and contact BD Biosciences for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell…
- Manufacturer
- BD Biosciences, Systems & Reagents
- Affected units
- 165
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 4220622
- Expiry 2016-04-30.
Distribution
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