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FilmArray Gastrointestinal (GI) Panel recallZ-1392-2023 · BioFire Diagnostics, LLC · initiated Mar 8, 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 manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

FDA root cause category: Under Investigation by firm

What the company is doing

On March 8, 2023, Biomerieux ( Parent company of BioFire Diagnostics, LLC) issued an "Urgent: Medical Device Correction" notification to affected consignees via E-Mail. In addition, to notifying affected consignees about the recalled device, Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for product identified in this recall (refer to Table 1). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty. 3. Please 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 your receipt of this notification. 4. If you have further distributed this product, please identify any recipients, and notify them at once of this product recall. 5. For product replacement, as well as any other questions or concerns, please contact our customer support department at [email protected] or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report online. " Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

Recall details

Recall number
Z-1392-2023
Status
Open, Classified
Initiated by the company
Mar 8, 2023
Posted by the FDA
Apr 14, 2023
Recalling firm
BioFire Diagnostics, LLC
Quantity
900 pouches (30 kits)
Product code
PCH
FDA submissions
K140407, K143005
Distribution
US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.

Product description

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Code information (models, lots, serial numbers)

Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

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 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page