FDA-Device2022-09-14Class II
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Abbott Molecular, Inc.
Hazard
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Sold states
Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.
Affected count
579 kits
Manufactured in
1300 E Touhy Ave, N/A, Des Plaines, IL, United States
Products
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1679-2022Don't want to check this manually?
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