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FilmArray Pneumonia Panel (Pneumo) recallZ-2039-2021 · BioFire Diagnostics, LLC · initiated Jun 7, 2021

Terminated

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 real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

FDA root cause category: Under Investigation by firm

What the company is doing

On 06/03/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter via overnight FedEx informing its customer that it has identified a potential for obtaining elevated rates of negative adenovirus results when using the pneumonia panel. The potential false negative results are due to a 10-100x reduction in sensitivity specifically for adenovirus species C when using the pneumonia panel kits within 6 months of expiration. In addition: -The test performance is NOT impacted if kits are more than 6 months from expiration date. -Performance for other adenovirus species (e.g. A, B, D, E, F, and G) are NOT affected -The adenovirus assays on all other of the Recalling Firm's Respiratory Panels are NOT affected. Customer are instructed to: 1) Immediately examine their inventory for product identified in this recall. -If the customer identifies any affected Pneumonia Panels in their inventory (i.e. Pneumonia Panels within 6 months of shelf-life), they may continue using the affected product; however, when adenovirus C infection is suspected, negative results for Adenovirus should be confirmed by another method prior to reporting test results to clinicians, or alternatively, the Recalling Firm's Pneumonia Panel Adenovirus negative results should not be reported. 2) If a customer has further distributed this product, they are to identify their customers and notify them at once of this product recall. 3) Complete the enclosed Acknowledgement of Receipt Form as soon as possible and return it to the Recalling Firm via one of the methods listed on the Acknowledgement of Receipt Form - 1) Fill out electronically using the following URL: (https://www.biofiredx.com/pn-5183/) 2) Scan to PDF and return completed form to: [email protected] Any questions or assistance - contact customer support department at [email protected] or via telephone 1-800-735-6544 option 5.

Recall details

Recall number
Z-2039-2021
Status
Terminated
Initiated by the company
Jun 7, 2021
Recalling firm
BioFire Diagnostics, LLC
Quantity
4,462 kits (Globally)
Product code
QBH
FDA submissions
K180966
Distribution
U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece , Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nicaragua, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.

Product description

FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)

Code information (models, lots, serial numbers)

Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 88117).

Sources and updates

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