VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V
Summary
The FDA issued a Class II for VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9. by bioMerieux, Inc.. Reason: There are 7 reported software anomalies that may affect use of the device..
Details
Source
Device Recall
External ID
Z-1640-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
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
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-13
Company
Durham, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 413 device-related FDA actions this month.
bioMerieux, Inc. has 146 FDA actions in our database, including 122 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (bioMerieux, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does bioMerieux, Inc. have FDA actions?
bioMerieux, Inc. has 146 FDA actions in our database, including 122 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1640-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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