Exact FDA event identifier

Event 87249

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 28, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Biomerieux Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1307-2021

Recall number: Z-1307-2021
Initiated: January 28, 2021
Classification: Class II
Status: Terminated
Recalling firm: Biomerieux Inc
Quantity: 8786 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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.

Distribution pattern

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.

device · product 2 of 2

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.

Z-1308-2021

Recall number: Z-1308-2021
Initiated: January 28, 2021
Classification: Class II
Status: Terminated
Recalling firm: Biomerieux Inc
Quantity: 6777 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

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)