Becton Dickinson Recalls BD MAX PCR Cartridges Due to Sealing Defects
Becton Dickinson & Co. is recalling BD MAX PCR Cartridges because they may not seal properly, potentially causing false or invalid test results.
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: The recall is classified as FDA Class II. The hazard involves potential false or invalid diagnostic results rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving significant but non-critical performance issues.
Plain-English summary
Becton Dickinson & Co. is recalling 27 boxes (648 cartridges) of BD MAX PCR Cartridges, Catalog #437519. These cartridges are in vitro diagnostic (IVD) consumables used with the BD MAX System to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures.
The recall was initiated because the cartridges are not sealing properly during PCR testing. This defect may cause false results, indeterminates, and/or invalid runs. The affected lot number is 2235001 with an expiration date of 2014-08-22.
The affected products were distributed worldwide, including in the United States (specifically CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI) and Belgium. Users of these cartridges should stop using them and contact Becton Dickinson & Co. for further instructions.
The recalled product
- Product
- BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detecti
- Manufacturer
- Becton Dickinson & Co.
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/Exp. date: 2235001 2014-08-22
Distribution
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