VITEK 2 (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.
Enforcement
- Recall Number
- Z-1307-2021
- Event ID
- 87249
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomerieux Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 31, 2021
- Initiation Date
- January 28, 2021
- Classification Date
- March 25, 2021
- Termination Date
- January 12, 2023
- Address
- 595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States
Description
VITEK 2 (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.
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).
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. (System: VITEK 2 60, Reference Number: 27225, Catalog Number: C20, UDI: 03573026162351); (System: VITEK 2 60, Reference Number: 27225R, Catalog Number: C20, UDI: 03573026206765); (System: VITEK 2 XL, Reference Number: 27227, Catalog Number: C20, UDI: 03573026162375); (System: VITEK 2 XL, Reference Number: 27227R, Catalog Number: C20, UDI: 03573026206789). Each instrument has unique serial number.
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.
8786 systems