Device Recall IMMULITE/IMMULITE 1000 Systems Androstenedione 의 리콜

Recall

67211

Class 2

Z-1531-2014

2013-12-20

2014-04-30

Terminated

United States

2017-02-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124991

Siemens healthcare diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/ml with the immulite/immulite 1000 and immulite 2000/immulite 2000 xpi androstenedione assays (lkao1, l2kao2). siemens has determined that these lots are linear up to a concentration of 5.5 ng/ml, instead of 10 ng/ml as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5 and 10 ng/ml will detect this issue.

The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated December 19, 2013, to its customers informing them that Siemens Healthcare Diagnostics has confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). The distribution of the customer communication began on 12/20/13 via FedEx (US). The letter described the product, problem and actions to be taken. Customers were instructed to take the following actions: - Please discuss this communication with your medical director. - Siemens recommends the use of Quality Control materials with at least two levels having concentrations less than 5.5 ng/mL. - Patient values of > 5.5 ng/mL should be verified using an alternate method. - and complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice within 30 days and fax to: CUSTOMER CARE CENTER at 302-631-7597. Field service personnel were sent a Service Knowledge Base (SKB) describing the issue and instructing them how to deal with customer questions. If you have any questions, please call 1-914-524-3074 or contact your Siemens Customer Care Center or your local Siemens technical support representative.