FDA (Devices) recall action 85203
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Extended Expiration Date prior to clearance
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.
Life Technologies is recalling 66 units of Oncomine Dx Target Test DNA Control-IVD because the expiration date was extended prior to clearance.
Life Technologies is recalling 35 units of the Oncomine Dx Target Test because the expiration date was extended prior to clearance.
Life Technologies is recalling 79 units of the Ion Torrent Dx No Template Control Kit due to extended expiration dates prior to clearance.
Life Technologies is recalling 66 units of the Oncomine Dx Target Test RNA Control because the expiration date was extended prior to regulatory clearance.