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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 Compact

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  Class 2 Device Recall VITEK 2 Compact see related information
Date Initiated by Firm January 28, 2021
Create Date March 25, 2021
Recall Status1 Terminated 3 on January 12, 2023
Recall Number Z-1308-2021
Recall Event ID 87249
510(K)Number K050002  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
Code Information VITEK 2 and VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7. Each instrument has unique serial number. (System: VITEK 2 Compact 60, Reference Number: 27560, Catalog Number: C57, UDI: 03573026136796); (System: VITEK 2 Compact 30, Reference Number: 27560R, Catalog Number: C57, UDI: 03573026147501); (System: VITEK 2 Compact 30, Reference Number: 27530, Catalog Number: C57, UDI: 03573026136789); (System: VITEK 2 Compact 30, Reference Number: 27530R, Catalog Number: C57, UDI: 03573026147495); (System: VITEK 2 Compact 15, Reference Number: 27415, Catalog Number: C57, UDI: 03573026220624); (System: VITEK 2 Compact 15, Reference Number: 27415R, Catalog Number: C57, UDI: 03573026220631) 
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Clinical Customer Support
800-682-2666
Manufacturer Reason
for Recall		 bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
FDA Determined
Cause 2		 Software design
Action The customer letter instructs the customer on how to verify the external communication configuration setting to see if they are impacted by this correction. If impacted, the customer will need to contact their local bioMerieux representative for instructions on how to verify expertised results until a correction is implemented. For a correction, customers can either convert to MYLA or BCI (where this issue will not occur) or continue to verify the expertised results until a software patch is deployed for 9.0x customers.
Quantity in Commerce 6777 systems
Distribution Worldwide distribution - No US consignees affected and the countries of Andorra, Austria, Bangladesh, Bermuda, Brazil, Brunei Darussalam, El Salvador, French Guiana, French Polynesia, Gibraltar, Greece, Guadeloupe, Guam, Holy See (Vatican City State), Hong Kong, Hungary, India, Indonesia, Ireland, Lao People's Democratic Republic, Luxembourg, Macao, Malaysia, Martinique, Mexico, Myanmar, New Caledonia, New Zealand, Nigeria, Philippines, Reunion, San Marino, Slovakia, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Uruguay.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LON and Original Applicant = BIOMERIEUX, INC.
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