In Vitro Diagnostic (IVD) Panel recallZ-1251-2023 · BioFire Diagnostics, LLC · initiated Feb 1, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Environmental control

What the company is doing

On 02/01/2023, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email to customers informing them of a "Temperature Out of Range" issue with multiple products, as a result from Hurricane Ian (10/2022) Customers are Instructed to: Immediately examine their inventory for product identified in this recall. 1. Discontinue use and discard any remaining product in their possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty. 2. Complete the accompanying Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to bioMerieux so that bioMerieux may acknowledge their receipt of this notification. 3. If customers have further distributed this product, please identify any recipients, and notify them at once of this product recall. For questions or concerns, contact customer support department at [email protected] or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support

Recall details

Recall number: Z-1251-2023
Status: Open, Classified
Initiated by the company: Feb 1, 2023
Posted by the FDA: Mar 15, 2023
Recalling firm: BioFire Diagnostics, LLC
Quantity: 2 kits
Product code: PEN
FDA submissions: K193519
Distribution: U.S. Nationwide distribution in the states of FL and GA.

Product description

In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

Code information (models, lots, serial numbers)

Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

BioFire® Blood Culture Identification 2 (BCID2) Panel RFIT-ASY-0147
Biofire Diagnostics, LLC · Gram-Positive Bacteria And Their Resistance Markers
6 recalls6 deaths555 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91647).

Z-1252-2023 · Open, Classified
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
Z-1253-2023 · Open, Classified
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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