BD Trucount Tubes for Blood Testing Recall Due to Label Detachment
Becton, Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together or create automation errors. The defect stems from an adhesive supplier change and affects 52,570 units.
What this means for you
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: This is an FDA Class II recall of a diagnostic medical device. Although no illnesses or injuries have been reported, partial label detachment poses a theoretical risk of test failures and automation errors that could affect patient diagnoses through incorrect test results.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling BD Trucount Tubes (Catalog Number 340334), which are used to determine absolute counts of white blood cells in blood samples. The tubes are designed for use with BD Tritest reagents and compatible flow cytometers.
The recall affects approximately 52,570 tubes distributed in the United States and internationally, including Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Paraguay, Singapore, Thailand, Taiwan, and Uruguay.
The issue is partial label detachment on the tubes. This defect can cause tubes to become stuck together in the pouch or to cause automation errors when used with the automated loader for the wash assistant. Becton, Dickinson's investigation confirmed the problem resulted from a change in adhesive supplied by a second-tier supplier.
Facilities and individuals using these tubes should discontinue use of the affected lot numbers and contact Becton, Dickinson for return and replacement instructions.
The recalled product
- Product
- BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the B
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Hazard
- label-detachment
- automation-error
- stuck-tubes
Distribution
Distributed in 43 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- NC
- ND
- NE
- NH
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
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