Z-1677-2018Class II

Immulite /Immulite 1000 Br-Ma (Ca15-3)

Name: Z-1677-2018 Immulite /Immulite 1000 Br-Ma (Ca15-3)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-01-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-01-02 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE /IMMULITE 1000 BR-MA (CA15-3) on 2018-01-02. FDA classified it as Class II and gives the reason as "Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1677-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-02
Posted: 2018-05-04
Terminated: 2023-02-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immulite /Immulite 1000 Br-Ma (Ca15-3)
Product code: MOI System, Test, Immunological, Antigen, Tumor
Reason for recall: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
Distribution: Nationwide and Canada, Mexico, and Thailand
Product codes and lots: BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2) Lot codes: 0312 0313

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1677-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1668-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1669-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1670-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1671-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1672-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1673-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1674-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1675-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1676-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1677-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1678-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1679-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1680-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1681-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1682-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1683-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1684-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1685-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1686-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1687-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1688-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1689-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1690-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1691-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code MOI

K013984Class IIImmulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2kbrDiagnostic Products Corp. / cleared 2002-03-28

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)