IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test)… recallZ-1700-2012 · Siemens Healthcare Diagnostics · initiated Apr 30, 2012

Terminated All recalls posted in June 2012

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Siemens Healthcare Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Component change control

What the company is doing

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.

Recall details

Recall number: Z-1700-2012
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Apr 30, 2012
Posted by the FDA: Jun 2, 2012
Recalling firm: Siemens Healthcare Diagnostics
Product code: CFP
FDA submissions: K022603
Distribution: Worldwide Distribution - US (nationwide)

Product description

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.

Code information (models, lots, serial numbers)

kit lot 0335

Other devices under the same FDA submission

1 device cleared under K022603 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

IMMULITE® 1000 Immunoassay System 10380058
Siemens Medical Solutions Diagnostics · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
7 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 61755).

Z-1701-2012 · Terminated
IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Test Code: INS, Color: Orange --- Product Usage: For in vitro diagnostic use with IMMULITE…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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