FDA (Devices) recall action 83879
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
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.
Ortho-Clinical Diagnostics is recalling VITROS K+ Slides because a mechanical failure may cause intermittent slide dispense issues.
Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because the anti-backup platen may fail to advance, causing intermittent slide dispense issues.
Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because an anti-backup platen failure may cause intermittent slide dispense issues.