Recall Z-1307-2021 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
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-
| Date | Jan 28, 2021 |
| Status | Terminated |
| Reason | bioMrieux 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). |
| Root cause | 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 | 8786 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, L |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050002 | VITEK 2 COMPACT bioMerieux, Inc., Feb 17, 2005 |