Reported Sep 18, 2013 · Terminated
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels…
Siemens Healthcare Diagnostics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 2040 Enterprise Blvd · West Sacramento, CA · 95691-3427
Is this the product you have?
- Microscan plus Negative Breakpoint Combo 4 Sold outside of US only
- Product UsageMicroScan¿ 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
- Lot codes and dates
Internal Number - B1016-203Catalog Number - 10460272
- Amount recalled
- 57,600 panels in total
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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