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FilmArray Gastrointestinal (GI) Panel recallZ-1253-2023 · BioFire Diagnostics, LLC · initiated Feb 1, 2023

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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-1253-2023
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
PCH
FDA submissions
K140407, K143005, K160459
Distribution
U.S. Nationwide distribution in the states of FL and GA.

Product description

In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

Code information (models, lots, serial numbers)

Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

1 device cleared under K140407, K143005, K160459 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

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

Sources and updates

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