MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

Class I - Dangerous

🏥 Medical Devices Recalled: November 3, 2015 bioMerieux Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
REF # 416546, Serial number/Software version V4.0 CLI
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: bioMerieux, Inc.
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

Product Codes/Lot Numbers:

REF # 416546, Serial number/Software version V4.0 CLI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0428-2016

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