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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Synergies Plus Negative Panels

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  Class 2 Device Recall MicroScan Synergies Plus Negative Panels see related information
Date Initiated by Firm July 31, 2008
Date Posted February 04, 2009
Recall Status1 Terminated 3 on November 29, 2010
Recall Number Z-0541-2009
Recall Event ID 49114
510(K)Number K870074  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product MicroScan Synergies Plus Negative Panels, 20 panels per box
Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria.

Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101
Code Information All lots
Recalling Firm/
Manufacturer		 Siemens Microscan
1584 Enterprise Blvd
West Sacramento CA 95691-3422
For Additional Information Contact Leslie Ardizone
916-374-3075
Manufacturer Reason
for Recall		 Falsely lowered imipenem MICs may result, leading to major errors in results.
FDA Determined
Cause 2		 Other
Action Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.
Quantity in Commerce Total of both Negative and Synergy: 569,375 boxes
Distribution Worldwide
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.
510(K) Database 510(K)s with Product Code = JWY and Original Applicant = MICROSCAN DIV. BAXTER HEALTHCARE CORP.
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