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FilmArray Pneumonia Panel (Pneumo) recallZ-0148-2027 · BioFire Diagnostics, LLC · initiated Aug 12, 2026

Open, Classified All recalls posted in October 2026

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 potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

FDA root cause category: Under Investigation by firm

What the company is doing

On 09/03/2026, an "URGENT: MEDICAL DEVICE RECALL (CORRECTION)" Letter was emailed to customers informing them that, bioMrieux internally identified increased rates of KPC unexpected positives in Quality Control (QC) testing of the BIOFIRE FILMARRAY PN Panel, BIOFIRE FILMARRAY PNplus Panel, and BIOFIRE JI Panel. Internal testing reproduced KPC unexpected positive results, suggesting KPC nucleic acid contamination in reagent manufacturing at levels that can lead to false positive results. Customers are instructed to: " Examine inventory for the lots identified in this recall. " If a positive KPC result obtained when using the affected product is inconsistent with local resistance epidemiology and clinical data, then the result should be confirmed with an alternative method. " If customer has further distributed or transferred this product to another facility, identify any recipients, notify them at once, and forward this notice. " Post the recall (correction) letter on or near affected products as a constant reminder of the actions that need to be taken. " Complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification. For questions - contact your local Customer Service Representative at 1-800-682-2666, selecting option 1 for Technical Support and option 3 for BIOFIRE, or email [email protected]

Recall details

Recall number
Z-0148-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Aug 12, 2026
Posted by the FDA
Oct 13, 2026
Recalling firm
BioFire Diagnostics, LLC
Quantity
4,892
Product code
QDP
FDA submissions
K243222
Distribution
Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.

Product description

Generic Name: FilmArray Pneumonia Panel Generic Name: FilmArray Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A

Code information (models, lots, serial numbers)

Lot Code: UDI nos 00815381020178 (30 pack), 00815381020185 (6 pack); Model Nos RFIT-PRT-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kit); Lot Numbers 0638726, 0676626, 0676726, 0716526, 0727826, 0767926, 0804526, 0804626, 0860926, 0882826, 0882926, 0883026, 0914626, 0914726, 0914826, 0914926, 0969126, 0969726, 0978026, 0978126, 0978226, 0978326, 0997626, 0997826, VK0997826, 0999226, 1020826, 1020926, 1105426, 1119126, 1119226, 1119326, 1119426, 1151826, 1152326, 1152426, 1179726, 1219026, 1267526, 1286226, 1286326, 1286426, 1346126, 1402726, 1402826, 1402926, 1419126, 1419226, 1437526, 1478926, 1560326, 1560426, 1560526, 1630726, 1656826, 1683726, 1702326, 1708826

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

2 devices cleared under K243222 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 99592).

Sources and updates

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