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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34

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  Class 2 Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34 see related information
Date Initiated by Firm June 16, 2011
Date Posted May 08, 2012
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-1498-2012
Recall Event ID 61610
510(K)Number K862140  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product MicroScan Dried Overnight Gram Negative Panels;

Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404.

Siemens Healthcare Diagnostics,
West Sacramento, CA.
Code Information lot code 2011-07-22. 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact Leslie Ardizone
916-374-0375
Manufacturer Reason
for Recall		 Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
FDA Determined
Cause 2		 Process control
Action Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.
Quantity in Commerce 680 boxes (20 panels per box)
Distribution Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
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 = AMERICAN MICRO SCAN
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