Reported Dec 23, 2015 · Terminated
MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology…
bioMerieux, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402
Is this the product you have?
- MYLA MASTER DVD V4.1
- CLI Product UsageMYLA is a computer application ( Middleware ) based on Web 2.0
- technology whichInterfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s))
- Lot codes and dates
REF # 417191Serial number/Software version V4.1 CLI
- Amount recalled
- 626 systems in total
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
This product could cause temporary or reversible health problems — stop using it.
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