CLASS II Device recall · Reported 19 Jun 2013 · FDA Enforcement Report
Siemens MicroScan Dried Negative Breakpoint Combo 47 panels recalled
Siemens Healthcare Diagnostics is recalling Siemens MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), distributed nationwide in the US. The recall was initiated on 2 May 2013 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-1525-2013
- FDA event ID
- 65188
- Recalling firm
- Siemens Healthcare Diagnostics, West Sacramento, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2013
- FDA classified
- 8 Jun 2013
- Reported
- 19 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 May 2013 | Recall initiated by company | |
| 8 Jun 2013 | Classified by FDA | +37 days |
| 19 Jun 2013 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
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 brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is Siemens MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099) recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099) on 2 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1525-2013.
Why was it recalled?
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
Which lots are affected?
Lot: 2013-11-13, Exp 11/13/2013.
Where was it sold?
Nationwide Distribution.
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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