FDA Device recall Z-0171-2015
Rapid Neg Urine Combo Panel Type 1
- FDA Device
- Class I
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class I recall of Rapid Neg Urine Combo Panel Type 1 by Siemens Healthcare Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0171-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-10-17 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
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.
Identifiers
| code_info | Catalog number: B1017-167, Siemens Material number 1044652, lot numbers: 2014-11-01, Exp. 2014-11-01; 2015-01-03, Exp…Catalog number: B1017-167, Siemens Material number 1044652, lot numbers: 2014-11-01, Exp. 2014-11-01; 2015-01-03, Exp 2015-01-03; 2015-02-14, Exp 2015-02-14; 2015-03-21, Exp 2015-03-21; 2015-05-20, Exp 2015-05-20; 2015-06-18, Exp 2015-06-18; 2015-07-18, Exp 2015-07-18; 2015-08-11, Exp 2015-08-11/ |
|---|
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-0171-2015%22
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