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DNA Genotek Inc. recalls ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.01
Recalled April 27, 2022 · FDA recall Z-0981-2022 · DNA Genotek
Hazard
Evaporation of stabilizing liquid reducing shelf life. · FDA Class II
Units
2,375,514 (US: 2,148,222 OUS: 227,292)
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.
Description
Evaporation of stabilizing liquid reducing shelf life.
Product
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
Manufacturer(s)
DNA Genotek Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →