FDA Devices recall · Reported March 31, 2021
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 inhibi
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, t…
Biomerieux Inc recalled VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the externa… - a moderate-severity action.
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the externa… was recalled by Biomerieux Inc in March 31, 2021. Reason: bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result ass…. Check the official notice for the remedy. Verify recall #Z-1308-2021 with the FDA Devices before acting.
The recall
Biomerieux Inc issued this moderate-severity FDA Devices recall-bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result ass….
- Moderate
- severity level
- Class II
- classification
- March 31, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1308-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1308-2021 |
| Date reported | March 31, 2021 |
| Date initiated | January 28, 2021 |
| Recalling firm | Biomerieux Inc |
| Firm location | Hazelwood, MO |
| Affected scope | 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 … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1308-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026