FDA (Devices) recall action 97787
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
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.
Meridian Bioscience is recalling Group B Streptococcus nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.
Meridian Bioscience is recalling alethia C. difficile nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.