Recall Z-1671-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
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.
| Date | May 1, 2019 |
| 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. |
| Root cause | Device Design |
| Action | On 05/01/2019 the firm sent an "Product Correction Urgent - Immediate Action Required" Letter and a "Customer Reply" form to customer via FedEx priority overnight express informing them that there is a potential for the mixer blade to separate from the mixer resulting in inadequate mixing of the reaction mixtures leading to potential incorrect results (failed assay calibration, Quality Control (QC) out of range, and/or incorrect patient results. The customer notification instructs customers to: 1. Immediately inspect mixers on your system(s) and verify the screw and mixer blade are present us |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |