Microscan plus Negative Combo 3 Sold outside of US only — Class I medical device recall Z-2124-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-09-18, distributed nationwide. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Syner
| Recall number | Z-2124-2013 |
|---|---|
| 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 | 2013-08-21 |
| Classified | 2013-09-11 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2014-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, DE, DZ, ES, FR, GB, GR, IE, IQ, IT, JP, OM, PL, PT, RO, SA, TR, ZA |
| Quantity | 57,600 panels |
| Model numbers | 10444600 |
Product
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Reason for recall
Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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-2124-2013. 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.