Class I — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems. |
| Product | Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli. |
| Quantity | 2239 |
| Distribution | Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada. |
| Initiated | 2014-10-17 |
| Classified | 2014-11-07 |
| Terminated | 2015-06-29 |
| Recall number | Z-0171-2015 |
| 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 I recall — Siemens Healthcare Diagnostics, Inc. (Z-0171-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69540/
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