Class II — Abbott Laboratories, Inc
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed. |
| Product | ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the reagent inside of the cuvettes. |
| Quantity | 09D59-01, 1010 products, 09D59-02, 25156 products, 09D59-03 13976 products |
| Distribution | Worldwide distribution US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, ME, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and St. Croix US Virgin Islands. Countries of AF, AL, AO, AR, AM, AU, AT, AZ, BS, BD, BV, BE, BA, BW, BR, BN, BG, BF, CA, CL, CN, CO, CR, HR, CY, C… |
| Initiated | 2019-05-01 |
| Classified | 2020-04-06 |
| Terminated | 2021-07-02 |
| Recall number | Z-1671-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories, Inc (Z-1671-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84995/
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