Lower riskMedical device recall · FDA · Published February 1, 2023
BioFire BCID2 Panel Recall: Temperature Issues May Reduce Performance
BioFire Diagnostics recalls BCID2 IVD Panel due to temperature excursions during shipping delays that may reduce performance. Affected units include specific lot numbers and model.
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Take action
Contact the company
📍Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
“BioFire BCID2 Panel Recall: Temperature Issues May Reduce Performance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58985-biofire-bcid2-panel-recall-temperature-issues-may-reduce-performance. Based on FDA recall #Z-1251-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2023%22&limit=1).
The FDA announced on Feb. 1, 2023, that BioFire Diagnostics, LLC is voluntarily recalling the In Vitro Diagnostic Panel BioFire BCID2 Panel due to potential performance reduction from temperature excursions during shipping. The agency issued recall number Z-1251-2023 for the Class II device.
How to tell if you have it
Brand: BioFire Diagnostics
Product: In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel
Reference Number: RFIT-ASY-0147
Part Number: RFIT-ASY-0147
UDI: 0815381020338
Lot Number: 1766022
Quantity: 2 kits
Distribution: U.S. Nationwide, including FL and GA
The hazard
The recall cites temperature excursions where products were stored outside required specifications as a result of shipping delays. These conditions may cause a reduction in performance for the diagnostic panels.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Recent brand recalls include false negative risks in the BioFire Respiratory Panel 2.1 (June 24, 2026) and false positive risks in the BioFire Joint Infection Panel (April 22, 2026). Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (July 16, 2026), Medline Convenience Kits: Temperature Probe Recall Due to Distribution Error (May 28, 2026), and Medline Convenience Kits Recall: Temperature Probes May Have Distribution Error (May 28, 2026).
How to tell if you have this one
Check for the product name 'BioFire BCID2 Panel' with part number RFIT-ASY-0147. The pouch lot number 1766022 identifies affected units.
Brand
BioFire Diagnostics
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
U.S. Nationwide distribution in the states of FL and GA.
Recall number
Product, codes & lots
Quantity
Z-1251-2023
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147; Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022
2 kits
Z-1252-2023
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742; Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622
8 kits
Z-1253-2023
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116; Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322
2 kits
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the part number RFIT-ASY-0147 and pouch lot number 1766022 to confirm if your panel is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of FL and GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1251-2023 (February 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1251-2023 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.