CLASS I Device recall · Reported 18 Sep 2013 · FDA Enforcement Report
Microscan Synergies Plus Negative Breakpoint Combo recalled
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Breakpoint Combo 7, distributed nationwide in the US. The recall was initiated on 21 Aug 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2121-2013
- FDA event ID
- 66058
- Recalling firm
- Siemens Healthcare Diagnostics, West Sacramento, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Aug 2013
- FDA classified
- 11 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 21 Aug 2013 | Recall initiated by company | |
| 11 Sep 2013 | Classified by FDA | +21 days |
| 18 Sep 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasMarylandMinnesotaMissouriSouth CarolinaSouth DakotaTexasWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
Internal Number B1025-109, Catalog Number - 10444748 Lot code/expiration date: 2012-08-17, 2012-08-17; 2012-10-06, 2012-10-06; 2012-12-08, 2012-12-08; 2013-01-09, 2013-01-09; 2013-03-02, 2013-03-02; 2013-04-12, 2013-04-12; 2013-06-15, 2013-06-15; 2013-08-06, 2013-08-06; 2013-09-24, 2013-09-24; 2013-12-07, 2013-12-07; 2014-01-08, 2014-01-08; 2014-01-31, 2014-01-31; 2014-03-25, 2014-03-25; 2014-05-09, 2014-05-09; 2014-07-01, 2014-07-01.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 66058This product is part of a recall event; the main page for the event is Microscan Synergies Plus Negative Urine Combo recalled.
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