FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127
FDA device recall Z-1513-2018 · posted 2018-04-25 · Terminated
Recall details
- Recalling firm
- BioFire Diagnostics, LLC
- 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.
- Action taken
- The recalling firm initiated the recall on several different dates and methods: Via email on 3/14/2018 with the letter dated 3/3/2018 attached, via USPS on 3/23/2018, and via FedEx between 3/24/2018 and 3/28/2018. The recalling firm conducted an expansion and issued letters dated 6/11/2018 via FedEx or USPS on 6/13/2018.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- PEN
- Distribution
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Co
- Date initiated
- 2018-03-14
- Date posted
- 2018-04-25
- Date terminated
- 2018-10-24
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (K160457) | Biofire Diagnostics, LLC | 2016-03-15 |
| FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 (K143171) | Biofire Diagnostics, LLC | 2015-01-30 |
| FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (K130914) | Biofire Diagnostics, Inc. | 2013-06-21 |