# FDA recall Z-1307-2021

> **Biomerieux Inc** · Class II · device recall initiated 2021-01-28.

## 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.

## 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).

## 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.

## Key facts

- **Recall number:** Z-1307-2021
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-28
- **Report date:** 2021-03-31
- **Termination date:** 2023-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1307-2021

## Citation

> AI Analytics. FDA recall Z-1307-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1307-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*