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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64699
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc.
City West Sacramento
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-06
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Nationwide Distribution including Puerto Rico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp. All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13. Class II Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems. 21,608 boxes = 432,160 panels Z-1272-2013
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