Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published October 11, 2021

BioFire BCID2 Blood Culture Panels Risk False Positive Acinetobacter Results

BioFire recalls BCID2 blood culture panels with possible false Acinetobacter calcoaceticus-baumannii complex results due to non-viable contamination in vials. Affected panels expire by April 30, 2022.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0312-2022Medical deviceBioFire ›
Take action

Contact the company

Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
✎ GovInfoNow plain-language explainer

BioFire Diagnostics recalls certain blood culture identification panels that may give false positive results for Acinetobacter calcoaceticus-baumannii complex. This could lead to incorrect infection diagnoses if used in medical settings. Read more at govinfonow.com/recall/61700-biofire-bcid2-blood-culture-panels-risk-false-positive-acinetobacter-results.

Source Summary by GovInfoNow · govinfonow.com/recall/61700-biofire-bcid2-blood-culture-panels-risk-false-positive-acinetobacter-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0312-2022

Cite this page

“BioFire BCID2 Blood Culture Panels Risk False Positive Acinetobacter Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61700-biofire-bcid2-blood-culture-panels-risk-false-positive-acinetobacter-results. Based on FDA recall #Z-0312-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0312-2022%22&limit=1).

The FDA announced on 2021-10-11 that BioFire Diagnostics, LLC is recalling the BioFire Blood Culture Identification 2 (BCID2) Panel due to an increased risk of false positive results for Acinetobacter calcoaceticus-baumannii complex. The agency stated the hazard may stem from non-viable contamination in the blood culture vials.

How to tell if you have it

  • Brand: BioFire
  • Product: BioFire Blood Culture Identification 2 (BCID2) Panel
  • Part Number: RFIT-ASY-0147
  • UDI: 00815381020338
  • Catalog Nos.: 442023, 442021, 442192, 442022, 442020
  • Expiration date: April 30, 2022 or earlier

The hazard

The recall addresses an increased risk of false positive Acinetobacter calcoaceticus-baumannii complex results. The FDA said the cause may be due to non-viable contamination in the blood culture vials.

Context

GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since 2018-03-14. Recent BioFire recalls include a 2026-06-24 recall of the Respiratory Panel 2.1 for false negatives, a 2026-04-22 Joint Infection Panel recall for false positives risk, and a 2026-04-01 Spotfire Respiratory Panel recall for false negatives risk. Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (2026-07-16), Biomerieux VITEK 2 Gram-negative Susceptibility Cards (2026-01-05), and Medline Blood Culture Kit Recall (2025-12-24).

How to tell if you have this one

Check for BioFire BCID2 Panel Part No: RFIT-ASY-0147 with UDI code 00815381020338. The panels expire by April 30, 2022 or earlier.

  • Brand
    BioFire
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Panel Expiry Date

    Verify the expiration date on the panel vials; affected units expire by April 30, 2022.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 47 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Oct 11, 202112. FDA classified it Class II: Nov 30, 202123. Published in FDA’s Enforcement Report: Dec 8, 202134. FDA terminated the recall: Aug 10, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0312-2022 (October 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0312-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA