Summary
The FDA issued a Class II for VITEK 2 Systems and VITEK 2 with MYLA. by bioMerieux, Inc.. Reason: Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-cor.
Details
Source
Device Recall
External ID
Z-1059-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
VITEK 2 Systems and VITEK 2 with MYLA.
Lot/Code Info: VITEK 2 - Versions 8.01, 9.01, 9.02 (with or without 9MR2), 9.03 (with or without #9MR2). VITEK 2 with MYLA - Versions 4.8 and 4.9.
Quantity Affected: 21,757 systems
Reason for Recall
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
Distribution
U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Serbia, Sweden, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-29
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 140 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-1059-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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