IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange Product Usage: For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Analyzers --- for the quantitative measurement of insulin in serum or heparinized plasma, for the management of diabetes.
This recall has been terminated (originally issued June 2, 2012).
- Company
- Siemens Healthcare Diagnostics
- Recall Initiated
- April 30, 2012
- Posted
- June 2, 2012
- Terminated
- March 16, 2017
- Recall Number
- Z-1700-2012
- Firm Location
- Tarrytown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
Distribution
Worldwide Distribution - US (nationwide)
Lot / Code Info
kit lot 0335
Root Cause
Component change control
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.