Reported Sep 18, 2013 · Terminated
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿…
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 Synergies Plus Negative
- Breakpoint Combo 7 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 B1025-109Catalog Number - 10444748
- Lot code/expiration date
2012-08-172012-08-172012-10-062012-10-062012-12-082012-12-082013-01-092013-01-092013-03-022013-03-022013-04-122013-04-122013-06-152013-06-152013-08-062013-08-062013-09-242013-09-242013-12-072013-12-072014-01-082014-01-082014-01-312014-01-312014-03-252014-03-252014-05-092014-05-092014-07-012014-07-01
- Amount recalled
- 4319 boxes, 86, 380 panels
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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