Biomerieux VITEK 2 Compact 30 Software Recall: Cards May Not Process Correctly
Biomerieux recalls VITEK 2 Compact 30 software and reagent cards that may stay in preliminary status after ejection, preventing further processing. Affected units were updated to software version 8.01.
Lower-risk recall
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Contact the company
What happened, in plain English
Biomerieux is recalling VITEK 2 Compact 30 software and reagent cards that may stay in preliminary status after being ejected from the instrument, preventing subsequent cards from processing. This issue occurs after a software update to version 8.01. Read more at govinfonow.com/recall/73434-biomerieux-vitek-2-compact-30-software-recall-cards-may-not.
Source Summary by GovInfoNow · govinfonow.com/recall/73434-biomerieux-vitek-2-compact-30-software-recall-cards-may-not · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3076-2017
Cite this page
“Biomerieux VITEK 2 Compact 30 Software Recall: Cards May Not Process Correctly.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73434-biomerieux-vitek-2-compact-30-software-recall-cards-may-not. Based on FDA recall #Z-3076-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3076-2017%22&limit=1).
Why it’s dangerous
Some VITEK 2 cards remain in preliminary status after being ejected from the instrument, causing subsequent cards in the carousel to not process correctly. This issue occurs after updating the system software to version 8.01.
Who’s affected
Laboratories using the VITEK 2 Compact 30 systems with software version 8.01 or newer are affected. Users of the clinical or industrial reagent cards with specific reference numbers are most at risk.
How to tell if you have this one
Check if your VITEK 2 Compact 30 system has software version 8.01 or newer. Affected reagent cards have reference numbers 27530, 27530R (clinical) or 27630, 17630R (industry).
- Brand
Biomerieux- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3075-2017 | VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.; VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01. | 1866 units |
| Z-3076-2017 | VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.; VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01. | 9234 units |
What to do — step by step
Check Software Version
Verify your VITEK 2 Compact 30 system software version; if it is 8.01 or newer, contact Biomerieux for assistance.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3076-2017 (July 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3076-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.