FDA (Devices) recall action 93514
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 organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
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.
Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.