Class 1 Device Recall Rapid Neg BP Combo Panel Type 3

• Date Initiated by Firm: October 17, 2014
• Date Posted: November 07, 2014
• Recall Status: Terminated on June 29, 2015
• Recall Number: Z-0170-2015
• Recall Event ID: 69540
• PMA Number: P870049
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. 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: B1017-117, Siemens Material number 1044632, lot numbers: 2014-12-10, Exp. 2014-12-10; 2015-02-27, Exp 2015-02-27; 2015-06-23, Exp 2015-06-23.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc. ; 2040 Enterprise Blvd; West Sacramento CA 95691-3427
• For Additional Information Contact: Jose Untalan; 916-374-3031
• 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: 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: 1381
• 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