Z-1700-2012

IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange

Name: Z-1700-2012 IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange
Creator: Siemens Healthcare Diagnostics
Published: 2012-04-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-04-30 / Terminated

FDA source

Siemens Healthcare Diagnostics began a recall of IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange Product Usage: For in vitro diagnostic use with... on 2012-04-30. The reason FDA records is "Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1700-2012
Status: Terminated
Initiated: 2012-04-30
Posted: 2012-06-02
Terminated: 2017-03-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: CFP Radioimmunoassay, Immunoreactive Insulin
Reason for recall: Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
FDA root cause: Component change control
Action: 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.
Distribution: Worldwide Distribution - US (nationwide)
Product codes and lots: kit lot 0335

Product code CFP

K022603Class IIImmulite 1000 Automated Immunoassay AnalyzerDiagnostic Products Corp. / cleared 2002-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)