FDA Device recall Z-2126-2013
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only
- FDA Device
- Class I
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class I recall of Microscan plus Negative Breakpoint Combo 4 Sold outside of US only by Siemens Healthcare Diagnostics, citing 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 Awa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2126-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-08-21 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Microscan plus Negative Breakpoint Combo 4 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
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.
Identifiers
| code_info | Internal Number - B1016-203; Catalog Number - 10460272 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2126-2013%22
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