Device Recall Dimension Sirolimus (SIRO) Flex reagent cartridge 의 리콜

Recall

73442

Class 2

Z-1633-2016

2016-02-09

Terminated

United States

2018-06-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144211

Siemens healthcare diagnostics has received customer complaints regarding qc shifts and imprecision after one day when using dimension¿ siro lot eb6064. they have confirmed siro lot # eb6064 does not meet the open well stability claim of 2 days.

Siemens sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: Discontinue use of and discard the kit lot listed in Table 1. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.