Rapid Neg BP Combo Panel Type 3 — Class I medical device recall Z-0170-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-11-19, distributed nationwide. An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo
| Recall number | Z-0170-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., West Sacramento, CA, United States |
| Recall initiated | 2014-10-17 |
| Classified | 2014-11-07 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,381 |
| Reason classes | microbial contamination |
| Model numbers | 1017-117, B1017-117 |
| Expiration dates | 2014-12-10, 2015-02-27, 2015-06-23 |
Product
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. 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.
Reason for recall
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.
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-0170-2015. 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.