Class II — Beckman Coulter, Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 681 boxes |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey. |
| Initiated | 2014-05-14 |
| Classified | 2015-04-26 |
| Terminated | 2015-04-27 |
| Recall number | Z-1522-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter, Inc. (Z-1522-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70874/
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