Biomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect
Biomerieux is recalling 8,786 VITEK 2 systems worldwide due to a software defect that may cause false susceptible results when using HL7 communication.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a 'potential safety risk worst case of a false susceptible erroneous test result,' which aligns with the rubric for Severe severity involving significant injury or risk of harm.
Plain-English summary
Biomerieux Inc is recalling 8,786 VITEK 2 systems, including VITEK 2 60 and VITEK 2 XL models, with version numbers 8.01, 8.02, 9.01, and 9.02. The recall affects systems configured with HL7 external communication. The distribution is worldwide, with no US consignees affected.
The recall is due to a software defect that prevents the system from sending expertised interpretation results and Therapeutic Corrections (TC) to Laboratory Information Systems (LIS) if an isolate is sent more than once. This can cause results in the VITEK 2 to not match those sent to the LIS, potentially leading to a false susceptible erroneous test result. Laboratory technicians may need to manually change results in the LIS to match the VITEK 2.
Healthcare facilities using these systems should contact Biomerieux for instructions on how to address the software defect. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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…
- Manufacturer
- Biomerieux Inc
- Affected units
- 8,786
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- VITEK 2 and VITEK 2 Compact (version numbers 8.01
- 8.02 (8.0x) and 9.01
- Reference Number: 27225
- Catalog Number: C20
- UDI: 03573026162351)
- (System: VITEK 2 60
- Reference Number: 27225R
- UDI: 03573026206765)
- (System: VITEK 2 XL
- Reference Number: 27227
- UDI: 03573026162375)
- Reference Number: 27227R
- UDI: 03573026206789). Each instrument has unique serial number.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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