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FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For… recallZ-2440-2023 · BioFire Diagnostics, LLC · initiated May 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, panels may result in false negative results.

FDA root cause category: Process design

What the company is doing

Between the dates of May 8, 2023 - May 11, 2023, Biomerieux ( Parent company of BioFire Diagnostics, LLC) issued an "Urgent: Medical Device Correction" notification to affected consignees via FedEx. 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-2440-2023
Status
Open, Classified
Initiated by the company
May 8, 2023
Posted by the FDA
Aug 21, 2023
Recalling firm
BioFire Diagnostics, LLC
Quantity
24 Kits (30 pouches/kit)
Product code
QBH
FDA submissions
K212727, K180966
Distribution
US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia

Product description

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

Code information (models, lots, serial numbers)

Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482

Devices named in this recall

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

Other devices under the same FDA submission

2 devices cleared under K212727, K180966 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 92397).

Sources and updates

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