—#121415

Product

Microscan plus Negative Combo 3 Sold outside of US only. 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.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K020246, K020249
Affected lot / code info: Internal Number - B1016-201; Catalog Number - 10444600

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Siemens sent an Urgent Field Safety Notice letters dated August 2013 to all US customers via over night delivery, receipt requested. Letters for foreign customers are being translated and will be sent as soon as possible. The letter identified the affected product, reason for field correction, risk to health problem and actions to be taken by customer. Customers were instructed to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that the customer consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. Customer were requested to complete the attached Field Correction Effectiveness Check form and fax it to 302-631-8467. For questions contact your Siemens Technical Support Provider or Distributor.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

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.

Timeline

Recall initiated: 2013-08-21
Posted by FDA: 2013-09-11
Terminated: 2014-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121415. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.