CLASS II Device recall · Reported 13 Aug 2014 · FDA Enforcement Report
Siemens Advia Centaur CP Immunoassay System Bnp kit recalled
Siemens Healthcare Diagnostics is recalling Siemens Advia Centaur CP Immunoassay System Bnp kit, distributed nationwide in the US. The recall was initiated on 23 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2150-2014
- FDA event ID
- 68665
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2014
- FDA classified
- 5 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Jun 2014 | Recall initiated by company | |
| 5 Aug 2014 | Classified by FDA | +43 days |
| 13 Aug 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints of failed calibration.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Where it was distributed
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Questions about this recall
Is Siemens Advia Centaur CP Immunoassay System Bnp kit recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Advia Centaur CP Immunoassay System Bnp kit on 23 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-2150-2014.
Why was it recalled?
Complaints of failed calibration.
Which lots are affected?
Lot# 38059172 and 39463172
Where was it sold?
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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