FDA Device recall Z-2123-2013
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels &
- FDA Device
- Class I
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class I recall of Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & 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-2123-2013 |
| 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 Synergies Plus Negative Urine Combo 5 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 - B1025-115; Catalog Number - 10483101 Lot code/expiration date: 2012-09-22, 2012-09-22; 2013-01-20…Internal Number - B1025-115; Catalog Number - 10483101 Lot code/expiration date: 2012-09-22, 2012-09-22; 2013-01-20, 2013-01-20; 2013-05-07, 2013-05-07; 2013-11-01, 2013-11-01; 2014-03-05, 2014-03-05. |
|---|
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-2123-2013%22
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