FDA Devices recall · Reported August 14, 2013
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from ver…
Biomerieux Inc recalled bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate… - a moderate-severity action.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate… was recalled by Biomerieux Inc in August 14, 2013. Reason: A product issue has been identified for customers using software version 6.01 and are interfaced with a Labor…. Check the official notice for the remedy. Verify recall #Z-1909-2013 with the FDA Devices before acting.
The recall
Biomerieux Inc issued this moderate-severity FDA Devices recall-A product issue has been identified for customers using software version 6.01 and are interfaced with a Labor….
- Moderate
- severity level
- Class II
- classification
- August 14, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1909-2013 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
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Reason for recall
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1909-2013 |
| Date reported | August 14, 2013 |
| Date initiated | June 14, 2013 |
| Recalling firm | Biomerieux Inc |
| Firm location | Hazelwood, MO |
| Affected scope | 12,384 total kits |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Eg… |
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-1909-2013) 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