Siemens Healthcare Diagnostics Inc — Class II medical device recall Z-1272-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-05-15, distributed nationwide. Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads wit
| Recall number | Z-1272-2013 |
|---|---|
| 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 | 2013-03-06 |
| Classified | 2013-05-08 |
| Reported by FDA | 2013-05-15 |
| Terminated | 2013-10-28 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination |
Product
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
Reason for recall
Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
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-1272-2013. 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.