Device Recall VITROS 5600 Integrated System 의 리콜

Recall

64577

Class 2

Z-1108-2013

2013-02-07

2013-04-13

Terminated

United States

2017-04-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116522

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 assembly. ocd's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.

URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS¿ System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.