ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Reported: June 4, 2014 Initiated: April 10, 2014 #Z-1659-2014
Product Description
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 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.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 16,302 kits.
Why was this product recalled? ▼
Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2014. Severity: Moderate. Recall number: Z-1659-2014.
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