MicroScan -Neg Breakpoint Combo Panel Type 34 — Class II medical device recall Z-1522-2015
Terminated recall by Beckman Coulter, Inc., reported 2015-05-06, distributed nationwide. Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the Micro
| Recall number | Z-1522-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., West Sacramento, CA, United States |
| Recall initiated | 2014-05-14 |
| Classified | 2015-04-26 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KW, TR, ZA |
| Quantity | 681 boxes |
| Reason classes | specification failure |
| Model numbers | B1017-404 |
| Expiration dates | 2014-05-28 |
Product
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria
Reason for recall
Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
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-1522-2015. 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.