BD Multitest 6-Color TBNK tubes recalled for partial label detachment
BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall with no reported illnesses or injuries. While the label defect presents a risk of automation errors in laboratory testing, no actual harm has been documented, making this a precautionary recall aligned with the Moderate severity category.
Plain-English summary
Becton, Dickinson and Company is recalling BD Multitest 6-Color TBNK with optional BD Trucount Tubes (catalog number 662995). These medical devices are used with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to measure lymphocyte subsets in blood samples for immunophenotyping tests.
The recall was initiated due to partial label detachment on the tubes. This defect can cause tubes to become stuck together in the pouch or result in automation errors when used with the automated loader for the wash assistant.
The recall affects 1,457 tubes with lot numbers 11568, 45905, 53637, 88003, 89111, and 31905. These devices were distributed in the United States and internationally to 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 FDA classified this as a Class II recall.
The recalled product
- Product
- BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Category
- Medical Device
- Hazard
- label-detachment
- equipment-malfunction
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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