Becton Dickinson Recalls BD BBL Taxo XV Factor Strips Due to Manufacturing Defects
Becton Dickinson is recalling 650 vials of BD BBL Taxo XV Factor Strips because they were not manufactured to specifications and may cause false negatives or misidentification of Hemophilus species.
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 is classified as FDA Class II. The hazard involves potential misdiagnosis of Hemophilus species due to false negatives or misidentification, which poses a significant risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling 650 vials of BD BBL Taxo XV Factor Strips, Catalog number 231104, Lot number 2089253. The product is distributed in shelf pack vials containing fifty strips each.
The recall was initiated because the in vitro diagnostic test kit was not manufactured according to specifications. This defect may cause false negatives or misidentification of Hemophilus species present in patient specimens.
The affected units were distributed worldwide, including nationwide in the United States and to international customers in Belgium, India, Japan, South Korea, Thailand, and Mexico. Users of this product should contact Becton Dickinson & Co. for further instructions.
The recalled product
- Product
- BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 650
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 number 2089253
Distribution
Distributed nationwide across the United States.
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