FDAClass IIApril 15, 2020

ARCHITECT C System Mixer - Product Usage: The ARCHITECT recall

ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing…

Why was ARCHITECT C System Mixer - Product Usage: The ARCHITECT 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LN 09D59-01, LN 09D59-02, LN 09D59-03

Product
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing…
Recalling firm
Abbott Laboratories, Inc
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, 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.
Recall date
April 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls