Device Recall IMMULITE Systems Rapid TSH 의 리콜

Recall

65162

Class 2

Z-1886-2013

2013-05-10

2013-08-06

Terminated

United States

2016-05-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118096

A rare variant of tsh, identified in a small cluster of patients, is not detected.

On May 10, 2013, an Important Safety Information notice was sent to all affected Siemens Healthcare Diagnostic customers in the United States. On May 10, 2013, an Urgent Field Safety Notice was sent to all customers outside of the United States. These notices inform the customer that there is a rare variant of TSH, identified in a small cluster of patients that is not detected by some Siemens assays. This notice informs customers that they should continue to use the affected TSH assays as the observed rate of occurrence during a 30-month time period was 0.6 X 10 -7 and there are strong mitigating factors. These mitigating factors include co-interpretation of TSH results in conjunction with thyroxine and TS, patient history and clinical signs and symptoms. Although Siemens believes a look back is not required as the expected frequency of the variant is extremely rare, these notices state that this decision should be made by the medical director.