VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and… recallZ-1308-2021 · Biomerieux Inc · initiated Jan 28, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomerieux Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1308-2021
- Status
- Terminated
- Initiated by the company
- Jan 28, 2021
- Recalling firm
- Biomerieux Inc
- Quantity
- 6777 systems
- Product code
- LON
- FDA submissions
- K050002
- 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 description
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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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)
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- VITEK® 2 COMPACT 27560Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall18 reports
- VITEK® 2 COMPACT 27530Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall5 reports
- VITEK® 2 COMPACT 27415Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall2 reports
- VITEK®2 Compact 27530RBiomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall0 reports
- VITEK®2 Compact 27560RBiomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall0 reports
- VITEK®2 Compact 27415RBiomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87249).
- Z-1307-2021 · TerminatedVITEK 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 inc…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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