Recall Z-2121-2013 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Sep 11, 2013 (initiated Aug 21, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 4319 boxes, 86, 380 panels |
| 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, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabi |
| FDA record | Open on fda.gov |