# FDA recall Z-1513-2018

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2018-03-14.

## Product

FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.

## Reason for recall

There is an increased risk of false positive Proteus results when the product is used with specific types of  BD BACTEC blood culture bottles.

## Distribution

Distribution was nationwide.  There was military/government distribution.  Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.

## Key facts

- **Recall number:** Z-1513-2018
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-14
- **Report date:** 2018-05-02
- **Termination date:** 2018-10-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2018

## Citation

> AI Analytics. FDA recall Z-1513-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1513-2018. Source: US FDA. Licensed CC0.

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