Device 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.
Z-1671-2020
Product summary
- Event
- Event 84995
- Status
- Terminated
- Classification
- Class II
- Quantity
- 09D59-01, 1010 products, 09D59-02, 25156 products, 09D59-03 13976 products
- Official record key
device-enforcement:Z-1671-2020
Official wording
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.
Code information: LN 09D59-01, LN 09D59-02, LN 09D59-03
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.