FDA (Devices) recall action 83406
The FDA (Devices) publishes a recall like this one as 19 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 19 pages.
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Becton Dickinson is recalling BD Max Enteric Viral Panel EU kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD Max MRSA XT kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD MAX Reagent extraction tube kits because foil bags may not be sealed properly.
Becton Dickinson is recalling BD Max Enteric Parasite Panel EU kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD Max StaphSR kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling 715 units of the Kit EXT Enteric Bacterial Panel because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD Max ExK TNA 2 kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.
Becton Dickinson is recalling 176 units of BD MAX MRSA Reagent Kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD Max StaphSR kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.
Becton Dickinson is recalling BD MAX Enteric Bacterial Panel kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling BD MAX Cdiff EU reagent kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling 27 units of BD Max Enteric Viral Panel RUO kits because foil bags containing extraction tubes may not have been sealed properly.
Becton Dickinson is recalling 666 BD Max Vaginal Panel kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD Max GC RT PCR Assay kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling 130 units of BD Max Check-Points CPO IVD kits because foil bags containing extraction tubes may not be sealed properly.
Becton Dickinson is recalling BD Max ExK DNA 2 USA kits because foil bags containing extraction tubes may not have been sealed properly.