FDAClass IIJune 4, 2014

ADVIA Centaur Systems VitD 100 test recall

ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of…

Why was ADVIA Centaur Systems VitD 100 test recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Kit lots ending in/Exp Date: 023 07 July 2014 024 08 September 2014 025 08 December 2014 026 09 February 2015 027 10 April 2015

Product
ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of…
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
17,731 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.
Recall date
June 4, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls