FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: 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.
- Recall number
- Z-0171-2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-10-17
- Posted
- 2014-11-07
- Terminated
- 2015-06-29
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Customer Recall notification letters were sent on October 17, 2014. Letters recommend that any remaining inventory be discarded and that consideration be given to reviewing previous test result, conduct patient follow up and/or repeat testing if isolates are still available. A second letter clarifying the recall was issued November 7, 2014 which provided additional information as requested by CDRH.
- Quantity
- 2239
- Distribution
- Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.
- Lot, serial or model codes
- 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/
- 510(k) numbers
- not on file
- PMA numbers
- ["P870049"]
- Product code
- LON
- Firm FEI
- 2919016
- Firm city
- West Sacramento
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28