FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Reported: September 18, 2024 Initiated: August 7, 2024 #Z-3122-2024
Product Description
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Reason for Recall
Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 1001
- Distribution
- Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W. Recalled by BioFire Diagnostics, LLC. Units affected: 1001.
Why was this product recalled? ▼
Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3122-2024.
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