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Recall Observatory FDA recall evidence

Device product

Microscan Synergies Plus Negative Urine 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-2122-2013

August 21, 2013

Class I

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 66058
Status
Terminated
Classification
Class I
Quantity
1,324 boxes, 26,480 panels
Official record key
device-enforcement:Z-2122-2013

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 - B1025-112 Catalog Number - 10444749 Lot code/expiration date: 2012-07-12, 2012-07-12; 2012-10-03, 2012-10-03; 2013-06-08, 2013-06-08; 2013-12-17, 2013-12-17; 2014-04-22, 2014-04-22; 2014-06-11, 2014-06-11;

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.