Z-1308-2021 Class II Terminated
Recalled by Biomerieux Inc
— Hazelwood, MO
FDA device recall Z-1308-2021 was initiated by Biomerieux Inc on January 28, 2021 and is designated Class II. 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 VIT… The recall status is terminated (terminated January 12, 2023). Affected quantity: 6777 systems.
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- January 28, 2021
- Termination Date
- January 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6777 systems
Product Description
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.
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).
Distribution Pattern
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.
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)