Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels — Class II medical device recall Z-1525-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-06-19, distributed nationwide. The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition,
| Recall number | Z-1525-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., West Sacramento, CA, United States |
| Recall initiated | 2013-05-02 |
| Classified | 2013-06-08 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2013-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 683 units |
| Expiration dates | 2013-11-13 |
Product
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1525-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.