bioMerieux, Inc.: VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9

Is my product affected?

VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9

• UPC 03573026553968
• UPC 03573026619060
• UPC 03573026609399
• UPC 03573026613914
• UPC 03573026619244
• UPC 03573026621568

Check against the official notice below — it lists the full affected range.

What happened

bioMerieux, Inc. has recalled VITEK 2 and MYLA VITEK 2 software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, and 9.03, as well as MYLA software versions V4.8 and V4.9. The recall was issued due to seven reported software anomalies that may affect the use of the device. The affected software was distributed internationally to Estonia, Bahrain, Pakistan, the UK, Singapore, Saudi Arabia, Thailand, and Vietnam.

The recall notice does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There are 7 reported software anomalies that may affect use of the device.

Details from the source

Reason for recall: There are 7 reported software anomalies that may affect use of the device. Distribution: International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam. Lot/code info: VITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9 UDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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