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BioFire Diagnostics, LLC

BioFire Diagnostics, LLC Recalls

All product recalls associated with BioFire Diagnostics, LLC.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

34

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4561–4580 of 21320 recalls

BioFire BCID2 Panel (BioFire) – Temperature Excursion (2023)

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.

FDAFeb 1, 2023Nationwide• BioFire Diagnostics, LLC

BD Ultra-Fine II Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

FDAFeb 1, 2023Nationwide• Becton Dickinson & Company

BD Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

1...227 228229230 231...1066

Page 229 of 1066Next

Feb 1, 2023

Nationwide

• Becton Dickinson & Company

Amaretto White Chocolate Torte (Epic Baking) – hidden ingredients (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared espresso, Yellow 5 and Yellow 6.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Dimension Tacrolimus Flex (Siemens) – Imprecision Issue (2023)

Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).

FDAJan 30, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

White Chocolate Amaretto Cheesecake (Epic Baking) – mislabeled nuts (2023)

Label does not list sub ingredients that include allergens. Label states, "May contain tree nuts" when the product actually contains almonds.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Red Velvet Torte (Epic Baking) – undeclared color (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared Red 40. Remaining major allergens were listed in contains statement and/or ingredient list.

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Banana Chocolate Chip Torte (Epic Baking) – Undeclared Ingredients (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Firm did not list yellow cake and it's ingredients. Undeclared Y5, R40, soy flour, soy lecithin and soybean oil.

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Strawberry Creme Torte (Epic Baking) – Undeclared Color (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared Blue 1; Yellow 5 and 6; Red 40. Remaining major allergens were listed in contains statement and/or ingredient list.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo B-52 Cheesecake (Epic Baking) – Incomplete Ingredients (2023)

Firm did not list sub-ingredients. All major allergens were listed in contains statement and/or ingredient list.

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo White Chocolate Raspberry Cheesecake (Epic Baking) – Incomplete Ingredients (2023)

Firm did not list sub-ingredients. All major allergens were listed in contains statement and/or ingredient list.

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Hazelnut Chocolate Cheesecake (Epic Baking) – Undeclared Hazelnut (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared hazelnut. Remaining major allergens were listed in contains statement and/or ingredient list.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Heavenly Lemon Torte (Epic Baking) – Undeclared Color (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared Yellow 5 and 6; Red 40. Remaining major allergens were listed in contains statement and/or ingredient list.

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Triple Chocolate Torte (Epic Baking) – Missing Allergens (2023)

Undeclared Milk

Missing ingredient statement. Undeclared Milk, Eggs, Wheat, Soy, Red 40

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Cannoli Cheesecake (Epic Baking) – Undeclared Color (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared Yellow 5 and Red 40.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Chocolate Candy Brownie Cheesecake (Epic Baking) – Undeclared Color (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared Blue 1 and 2; Yellow 5 and 6; Red 4 and 40.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Traditional Cheesecake (Epic Baking) – ingredient disclosure (2023)

Firm did not list sub-ingredients. All major allergens were listed in contains statement and/or ingredient list.

FDAJan 30, 2023GA, TN• Epic Baking

Key Lime Cheesecake (Epic Baking) – undeclared colors (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared Yellow 5 and Blue 1. Remaining major allergens were listed in contains statement and/or ingredient list.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Party Time Torte (Epic Baking) – multiple undeclared allergens (2023)

Undeclared Milk

Missing ingredient statement. Undeclared Milk, Egg, Wheat, Soy, Red 40, Red 3, Yellow 5, Yellow 6, Blue 1

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking

Cafe' Intermezzo Carrot Torte (Epic Baking) – Undeclared Ingredients (2023)

Undeclared Allergen

Firm did not list sub-ingredients. Undeclared Yellow 5 and Red 40.

Class IIModerate

FDAJan 30, 2023GA, TN• Epic Baking