Class 2 Device Recall ARCHITECT Clinical Chemistry Systems

• Date Initiated by Firm: May 01, 2019
• Create Date: April 06, 2020
• Recall Status: Terminated on July 02, 2021
• Recall Number: Z-1671-2020
• Recall Event ID: 84995
• 510(K)Number: K980367
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• 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.
• Code Information: LN 09D59-01, LN 09D59-02, LN 09D59-03
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Dr; Irving TX 75038-4313
• For Additional Information Contact: Albert Chianello; 224-668-1923
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 using the instructions in Appendix A (of the notification). 2. Incorporate the Mixer Inspection Procedure, in Appendix A, into your daily maintenance activities. (Note: For customers that have the premium software feature, a user defined daily maintenance procedure may be created to inspect the mixers. Refer to User-Defined maintenance (Premium feature). 3. If you hear an unusual noise generated from the rear of the instrument in the mixer area, inspect the mixer for a missing screw and/or mixer blade. Please follow instructions located in Appendix A. 4. If you observe one of the error codes listed in Appendix B, immediately verify the mixer is intact using the Mixer Inspection Procedure located in Appendix A and perform the Cuvette Inspection Procedure in Appendix C. 5. During your routine weekly maintenance procedure 6021 Clean Mixers. Please follow the additional precautions provided in Appendix D. If you become aware of a mixer with a detached blade, please consult your medical director regarding previously generated results. The Recalling Firm will provide updated information of these procedures once the investigation on the mixers is completed. The Notification also states, if you have forwarded the product to other laboratories, to please inform them of this Product Correction and provide a copy of the letter. If you or any of the health care providers
• Quantity in Commerce: 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, CZ, CD, DK, DO, EC, EG, SV, EE, ET, FI, FR, GE, DE, GR, GT, HN, HK, HU, IN, ID, IQ, IE, IL, IT, JM, JO, KZ, KE, KW, KG, LV, LB, LY, LT, LU, MK, MW, MY, MV, ML, MR, MX, MD, MA, MM, NA, NL, NZ, NG, NO, OM, PK, PA, PE, PH, PL, PT, PY, QA, RO, RU, RW, SA, SN, SG, SK, SI, ZA, ES, SE, CH, TW, TJ, TZ, TH, TT, TN, TC, TR, AE, UG, UK, UA, UY, VE, VN, YE, ZM, ZW, LC, MS, ME, VC, LK, RS, KY, CW, GZA, JRH, CI, KR.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE