Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapi

FDA device recall Z-2124-2013 · posted 2013-09-11 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LON

Quantity affected

57,600 panels in total

Distribution

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, Russ

Date initiated

2013-08-21

Date posted

2013-09-11

Date terminated

2014-05-15

Location

West Sacramento, CA

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