PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 15, 2020 Initiated: May 1, 2019 #Z-1671-2020

Product Description

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.

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.

Details

Recalling Firm
Abbott Laboratories, Inc
Units Affected
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.
Location
Irving, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by Abbott Laboratories, Inc. Units affected: 09D59-01, 1010 products, 09D59-02, 25156 products, 09D59-03 13976 products.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 15, 2020. Severity: Moderate. Recall number: Z-1671-2020.