Z-1659-2014Class II

ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883

Name: Z-1659-2014 ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2014-04-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-04-10 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883 on 2014-04-10. FDA classified it as Class II and gives the reason as "Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1659-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-10
Posted: 2014-05-23
Terminated: 2016-05-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Product code: NTM Antigen, Inflammatory Response Marker, Sepsis
Reason for recall: Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare Urgent Medical Device Correction (UMDC) was mailed to all affected Siemens Healthcare Diagnostics customers in the United States on April 11, 2014 for customer receipt on April 14, 2014. This notice informed the customers of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra and Vitamin D Total assays. This notice instructs customers that the TSH3-Ultra and Vitamin D assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facility's laboratory or medical director. B. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on April 10, 2014. This notice informed the customer of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra , Vitamin D Total and ADVIA Centaur BRAHMS Procalcitonin assays. This notice instructs customers that the TSH3-Ultra, Vitamin D and Procalcitonin assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facilitys laboratory or medical director. (Note: The ADVIA Centaur BRAHMS Procalcitonin assay is not sold in the US.)
Quantity in commerce: 16,302 kits
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
Product codes and lots: Kit lots ending in/Exp Date: 020 11 July 2014 021 15 December 2014 022 24 February 2015 023 25 February 2015 024 03 July 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1659-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1653-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23
Z-1654-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23
Z-1655-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23
Z-1656-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23
Z-1657-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23
Z-1658-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23
Z-1659-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-23

Product code NTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)