IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Sie

FDA device recall Z-1532-2014 · posted 2014-04-30 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CIZ

Quantity affected

7741

Distribution

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great

Date initiated

2013-12-20

Date posted

2014-04-30

Date terminated

2017-02-28

Location

Tarrytown, NY