Device product
Microscan Synergies Plus Negative Urine Combo 1 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-2119-2013
Product summary
- Event
- Event 66058
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1209 boxes, 24, 180 panels
- Official record key
device-enforcement:Z-2119-2013
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 - B1025-106; Catalog Number -10444745; Lot code/expiration date: 2012-12-05, 2012-12-05; 2013-01-16, 2013-01-16; 2013-02-28, 2013-02-28; 2014-01-11, 2014-01-11; 2014-02-11, 2014-02-11; 2014-05-21, 2014-05-21.
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
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.