ADVIA Centaur¿¿ Systems HBc Total recall
ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA…
Why was ADVIA Centaur¿¿ Systems HBc Total recalled?
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
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?
Lot Number: 36217064, 36281064, 36449064, 37406064, 38177064 Exp.Date:February 10, 2015
- Product
- ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 5434
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
- Recall date
- October 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)