Z-1307-2021Class II

VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured...

Name: 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...
Creator: Biomerieux Inc
Published: 2021-01-28
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-01-28 / Terminated / root cause: software

FDA source

Biomerieux Inc began a recall of 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... on 2021-01-28. FDA classified it as Class II and gives the reason as "bioMrieux 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1307-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-28
Posted: 2021-03-25
Terminated: 2023-01-12
Recalling firm: bioMerieux, Inc.
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 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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: bioMrieux 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).
Root cause tag: software
FDA root cause: Software design
Action: The customer letter instructs the customer on how to verify the external communication configuration setting to see if they are impacted by this correction. If impacted, the customer will need to contact their local bioMerieux representative for instructions on how to verify expertised results until a correction is implemented. For a correction, customers can either convert to MYLA or BCI (where this issue will not occur) or continue to verify the expertised results until a software patch is deployed for 9.0x customers.
Quantity in commerce: 8786 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1307-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1307-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-25
Z-1308-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-25

Product code LON

K050002Class IIVitek 2 CompactbioMerieux, Inc. / cleared 2005-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)