CLASS II Device recall · Reported 13 Jan 2016 · FDA Enforcement Report
Siemens Acute Care pBNP TestPak recalled
Siemens Healthcare Diagnostics is recalling Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative, distributed nationwide in the US. The recall was initiated on 11 Nov 2015 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-0610-2016
- FDA event ID
- 72570
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2015
- FDA classified
- 7 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Nov 2015 | Recall initiated by company | |
| 7 Jan 2016 | Classified by FDA | +57 days |
| 13 Jan 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
Where it was distributed
Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Questions about this recall
Is Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative on 11 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0610-2016.
Why was it recalled?
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Which lots are affected?
Lot Numbers: 215166002, 215194002, 215222002, 215271002
Where was it sold?
Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., 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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