Z-1671-2020Class II

ARCHITECT C System Mixer -

Name: Z-1671-2020 ARCHITECT C System Mixer -
Creator: Abbott Laboratories, Inc
Published: 2019-05-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-05-01 / Terminated / root cause: design

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and... on 2019-05-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1671-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-01
Posted: 2020-04-06
Terminated: 2021-07-02
Recalling firm: Abbott Medical
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: LN 09D59-01, LN 09D59-02, LN 09D59-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1671-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1671-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-06

Product code JJE

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)