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Recall Observatory FDA recall evidence

Device product

Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

Z-2120-2013

August 21, 2013

Class I

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 66058
Status
Terminated
Classification
Class I
Quantity
2158 boxes, 43,160 panels
Official record key
device-enforcement:Z-2120-2013

Official wording

Reason: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

Code information: Internal Number - B1025-108; Catalog Number - 10444747; Lot code/expiration date: 2012-06-27, 2012-06-27; 2012-08-10, 2012-08-10; 2012-10-12, 2012-10-12; 2012-11-30, 2012-11-30; 2013-01-06, 2013-01-06; 2013-02-01, 2013-02-01; 2013-03-27, 2013-03-27; 2013-10-02, 2013-10-02; 2013-11-21, 2013-11-21; 2014-01-24, 2014-01-24; 2014-03-28, 2014-03-28; 2014-05-03, 2014-05-03.

Distribution pattern: Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.