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Recall Observatory FDA recall evidence

Device product

Microscan Synergies Plus Negative Breakpoint Combo 7 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-2121-2013

August 21, 2013

Class I

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 66058
Status
Terminated
Classification
Class I
Quantity
4319 boxes, 86, 380 panels
Official record key
device-enforcement:Z-2121-2013

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 B1025-109, Catalog Number - 10444748 Lot code/expiration date: 2012-08-17, 2012-08-17; 2012-10-06, 2012-10-06; 2012-12-08, 2012-12-08; 2013-01-09, 2013-01-09; 2013-03-02, 2013-03-02; 2013-04-12, 2013-04-12; 2013-06-15, 2013-06-15; 2013-08-06, 2013-08-06; 2013-09-24, 2013-09-24; 2013-12-07, 2013-12-07; 2014-01-08, 2014-01-08; 2014-01-31, 2014-01-31; 2014-03-25, 2014-03-25; 2014-05-09, 2014-05-09; 2014-07-01, 2014-07-01.

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.