Lower risk Medical device recall · FDA · Published January 28, 2021

Biomerieux VITEK 2 Compact: False Test Results Risk with HL7 Connection

Biomerieux recalls VITEK 2 Compact (versions 8.01-9.02) with HL7 configured external communication due to potential false susceptible test results. Lab technicians may need to manually correct LIS results, risking incorrect treatment decisions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1308-2021Medical device Biomerieux ›

Lower-risk 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).

Take action

Contact the company

Recalling firmBiomerieux Inc595 Anglum Rd · Hazelwood, MO 63042-2320

✎ GovInfoNow plain-language explainer

Biomerieux is recalling certain VITEK 2 Compact systems that may send false test results to laboratory information systems when connected via HL7. This could lead to incorrect treatment decisions if lab technicians have to manually adjust results. Affected units have specific version numbers and HL7 configuration. Read more at govinfonow.com/recall/63338-biomerieux-vitek-2-compact-false-test-results-risk-with-hl7.

Source Summary by GovInfoNow · govinfonow.com/recall/63338-biomerieux-vitek-2-compact-false-test-results-risk-with-hl7 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1308-2021

Cite this page

“Biomerieux VITEK 2 Compact: False Test Results Risk with HL7 Connection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63338-biomerieux-vitek-2-compact-false-test-results-risk-with-hl7. Based on FDA recall #Z-1308-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1308-2021%22&limit=1).

The FDA announced on Jan. 28, 2021, that Biomerieux Inc is recalling VITEK 2 Compact systems due to a potential safety risk of false susceptible test results. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Biomerieux
Product: VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x))
Configuration: External communication configured to HL7
Units affected: 6777 systems

The hazard

BioMérieux identified a potential safety risk where the worst case is a false susceptible erroneous test result. The problem occurs when HL7 Connection is used, causing results in the VITEK 2 to not match those sent to the LIS, or preventing expert interpretation results and Therapeutic Corrections from being sent if an isolate is sent more than once.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since 2017-07-12. Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24), Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04), and Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (2026-01-05). Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30: False Susceptibility Results Risk (2026-06-08), BioFire Respiratory Panel 2.1 Recall: False Negatives Risk (2025-10-22), and Vivoo Vaginal pH Test Recall: False Results Risk Inappropriate Medical Treatment (2025-11-22).

How to tell if you have this one

Check if your VITEK 2 Compact has version numbers 8.01, 8.02 (8.0x), 9.01, or 9.02 (9.0x) with HL7 external communication configured. Each unit has a unique serial number and specific reference numbers.

Brand
Biomerieux
Category
Medical device

FDA recall event · 2 products

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 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, Lao People's Democratic Republic, Luxembourg, Macao, Malaysia, Martinique, Mexico, Myanmar, New Caledonia, New Zealand, Nigeria, Philippines, Reunion, San Marino, Slovakia, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Uruguay.

Recall number	Product, codes & lots	Quantity
Z-1307-2021	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-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.; VITEK 2 and 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: VITEK 2 60, Reference Number: 27225, Catalog Number: C20, UDI: 03573026162351); (System: VITEK 2 60, Reference Number: 27225R, Catalog Number: C20, UDI: 03573026206765); (System: VITEK 2 XL, Reference Number: 27227, Catalog Number: C20, UDI: 03573026162375); (System: VITEK 2 XL, Reference Number: 27227R, Catalog Number: C20, UDI: 03573026206789). Each instrument has unique serial number.	8786 systems
Z-1308-2021	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 inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.; VITEK 2 and 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. Each instrument has unique serial number. (System: VITEK 2 Compact 60, Reference Number: 27560, Catalog Number: C57, UDI: 03573026136796); (System: VITEK 2 Compact 30, Reference Number: 27560R, Catalog Number: C57, UDI: 03573026147501); (System: VITEK 2 Compact 30, Reference Number: 27530, Catalog Number: C57, UDI: 03573026136789); (System: VITEK 2 Compact 30, Reference Number: 27530R, Catalog Number: C57, UDI: 03573026147495); (System: VITEK 2 Compact 15, Reference Number: 27415, Catalog Number: C57, UDI: 03573026220624); (System: VITEK 2 Compact 15, Reference Number: 27415R, Catalog Number: C57, UDI: 03573026220631)	6777 systems

Based on the official FDA remedy

What to do — step by step

Check System Version
Verify your VITEK 2 Compact's version number (8.01, 8.02, 9.01, or 9.02) and HL7 configuration.

How this recall unfolded

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Jan 28, 2021Firm started the recall
Mar 25, 2021FDA classified it Class II
Mar 31, 2021Published in FDA’s Enforcement Report
Jan 12, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63338-biomerieux-vitek-2-compact-false-test-results-risk-with-hl7">Biomerieux VITEK 2 Compact: False Test Results Risk with HL7 Connection (GovInfoNow)</a>

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-1308-2021 (January 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1308-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.