—#126661

Product

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

FDA product code: NTM — Antigen, Inflammatory Response Marker, Sepsis
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: 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

Why it was recalled

Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Root cause (FDA determination)

Device Design

Action the firm took

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.)

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-04-10
Posted by FDA: 2014-05-23
Terminated: 2016-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.