FDA (Devices) recall action 64577
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.
Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assem…
Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment asse…
The agency’s own wording, quoted from the enforcement report.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because extension springs may be out of specification, potentially causing imprecise chemistry test results.
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.