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
Reported: April 27, 2022 Initiated: February 18, 2022 #Z-0981-2022
Product Description
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
Reason for Recall
Evaporation of stabilizing liquid reducing shelf life.
Details
- Recalling Firm
- DNA Genotek Inc.
- Units Affected
- 2,375,514 (US: 2,148,222 OUS: 227,292)
- Distribution
- 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.
- Location
- Kanata
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by DNA Genotek Inc.. Units affected: 2,375,514 (US: 2,148,222 OUS: 227,292).
Why was this product recalled? ▼
Evaporation of stabilizing liquid reducing shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0981-2022.
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