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U.S. Department of Health and Human Services

Class 1 Device Recall Rapid Neg Urine Combo Panel Type 1

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  Class 1 Device Recall Rapid Neg Urine Combo Panel Type 1 see related information
Date Initiated by Firm October 17, 2014
Date Posted November 07, 2014
Recall Status1 Terminated 3 on June 29, 2015
Recall Number Z-0171-2015
Recall Event ID 69540
PMA Number P870049 
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
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.
Code Information 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/
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact Jose Untalan
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LON and Original Applicant = DADE INTL., INC.