IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Test Code: INS, Color: Orange --

FDA device recall Z-1701-2012 · posted 2012-06-02 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

Reason for recall

Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.

Action taken

Siemens sent an Urgent Device Recall letter dated April 2012 via fax to affected U.S. customers and an Urgent Field Safety Notice to customers outside the U.S. The letter identified the affected kit lots, reason for voluntary recall, risk to health and actions to be taken by the customer/user. Customers were instructed to discard any inventory of the affected kit lots and complete and return the attached Field Correction Effectiveness Check questionnaire within thirty (30) days to request a no-charge replacement kits. Customers were requested to post this field correction by each IMMULITE system to alert users to the situation. For questions contact your Siemens Technical Solutions Center.

Root cause

Component change control

Status

Terminated

Product code

CFP

Distribution

Worldwide Distribution - US (nationwide)

Date initiated

2012-04-30

Date posted

2012-06-02

Date terminated

2017-03-16

Location

Tarrytown, NY

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