Z-1273-2012

IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests)...

Name: Z-1273-2012 IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests)...
Creator: Siemens Healthcare Diagnostics
Published: 2012-01-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-01-25 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics began a recall of IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue. For in vitro... on 2012-01-25. The reason FDA records is "Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1273-2012
Status: Terminated
Initiated: 2012-01-25
Posted: 2012-03-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE 2000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
Product code: JHX Fluorometric Method, Cpk Or Isoenzymes
Reason for recall: Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an "URGENT DEVICE RECALL" letter dated January 2012 to all affected customers. The letter identifies the product , problem, and actions to be taken by the customers. Siemens recommends that customers reestablish their own medians and reference ranges, in line with the recommendations made in the IFU for these products. A Field Correction Effectiveness Check form was included for customers to complete and return to the firm. Customers with questions or who need additional information should contact their Siemens Technical Solutions Center.
Distribution: Worldwide Distribution.
Product codes and lots: kit lot 213, 214, 215

Product code JHX

K004002Class IIImmulite Ck-Mb, Model Lkmb1 (100 Tests), Lkmb5 (500 Tests); Immulite 2000 Ck-Mb, Model L2kmb2 (200 Tests), L2kmb6 (600)Diagnostic Products Corp. / cleared 2001-02-14

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)