FDA (Devices) recall action 77209
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
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.
Cell Marque is recalling HHV-8 in vitro diagnostic reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling Her2/Neu (c-erbB-2) reagents because they were not labeled as 'For Export Only' as required by law.
Cell Marque is recalling Varicella Zoster Virus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling Her2/Neu (EP3) reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling Herpes Simplex Virus I reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling 8 units of Estrogen Receptor reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling five units of H. pylori reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling three units of SV40 (MRQ-4) reagent because they were not labeled 'For Export Only' as required by law.
Cell Marque is recalling Adenovirus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling specific lots of Estrogen Receptor reagents because they were not labeled 'For Export Only' as required by law.
Cell Marque is recalling CD117, c-kit reagents because they were not labeled 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling specific lots of Herpes Simplex Virus II reagents because they were not properly labeled as 'For Export Only' as required by federal law.