FDA (Devices) recall action 69276
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
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.
Richard-Allan Scientific is recalling 175 cases of Protocol 10% NBF tissue fixative because the concentration may be outside specifications.
Richard-Allan Scientific is recalling Bio-Tite Specimen Containers because the NBF concentration may be outside specifications.
Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.
Richard-Allan Scientific is recalling 285 cases of its Specimen Transportation System because the NBF concentrations may not meet specifications.
Richard-Allan Scientific is recalling 10% Neutral Buffered Formalin because the concentration may be outside specifications. The product is used to fixate tissue for histological examination.
Richard-Allan Scientific is recalling 264 cases of its Specimen Transportation System because the NBF concentration may be outside specifications.
Richard-Allan Scientific is recalling 199 cases of 10% Neutral Buffered Formalin because the chemical concentration may be outside of desired specifications.