CLASS II Device recall · Reported 10 Mar 2021 · FDA Enforcement Report
BioFire BCID2 Panel recalled by BioFire Diagnostics
BioFire Diagnostics is recalling BioFire BCID2 Panel, distributed nationwide in the US. The recall was initiated on 26 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1158-2021
- FDA event ID
- 87282
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2021
- FDA classified
- 1 Mar 2021
- Reported
- 10 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 26 Jan 2021 | Recall initiated by company | |
| 1 Mar 2021 | Classified by FDA | +34 days |
| 10 Mar 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.
Questions about this recall
Is BioFire BCID2 Panel recalled?
Yes. BioFire Diagnostics recalled BioFire BCID2 Panel on 26 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1158-2021.
Why was it recalled?
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Which lots are affected?
All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BioFire Diagnostics
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS II | Biofire Spotfire Respiratory/Sore Throat Panel recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | BioFire Joint Infection (JI) Panel recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS II | BioFire Respiratory Panel 1, IVD recalled by BioFire Diagnostics | BioFire Diagnostics | Device Malfunction | 10 states |
| Device | CLASS II | BioFire Respiratory Panel 1 plus Kit recalled by BioFire Diagnostics | BioFire Diagnostics | Device Malfunction | Nationwide |
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