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FDAFDA · Food and drugs·Recall number Z-0681-2024

Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

Published January 17, 2024 · Recall initiated: October 19, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Abbott Laboratories
Distributor
U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil
Lot
List Number: 03R67-01 Serial Numbers / UDI-DI codes (U.S. systems): AC01225 (01)00380740137380(21)AC01225 AC01226 (01)00380740137380(21)AC01226 AC01256 (01)00380740137380(21)AC01256 AC01257 (01)00380740137380(21)AC01257 AC01263 (01)00380740137380(21)AC01263 AC01264 (01)00380740137380(21)AC01264 AC01273 (01)00380740137380(21)AC01273 AC01274 (01)00380740137380(21)AC01274 AC01275 (01)00380740137380(21)AC01275 AC01356 (01)00380740137380(21)AC01356 AC01357 (01)00380740137380(21)AC01357 AC01358 (01)00380740137380(21)AC01358 AC01503 (01)00380740137380(21)AC01503 AC01504 (01)00380740137380(21)AC01504 AC01505 (01)00380740137380(21)AC01505 AC01506 (01)00380740137380(21)AC01506 AC01507 (01)00380740137380(21)AC01507 AC01508 (01)00380740137380(21)AC01508 AC01509 (01)00380740137380(21)AC01509 AC01510 (01)00380740137380(21)AC01510 AC01512 (01)00380740137380(21)AC01512 AC01513 (01)00380740137380(21)AC01513 AC01518 (01)00380740137380(21)AC01518 AC01521 (01)00380740137380(21)AC01521 AC01522 (01)00380740137380(21)AC01522 AC01523 (01)00380740137380(21)AC01523 AC01553 (01)00380740137380(21)AC01553 AC01554 (01)00380740137380(21)AC01554 AC01561 (01)00380740137380(21)AC01561 AC01566 (01)00380740137380(21)AC01566 AC01582 (01)00380740137380(21)AC01582 AC01584 (01)00380740137380(21)AC01584 AC01585 (01)00380740137380(21)AC01585 AC01588 (01)00380740137380(21)AC01588 AC01589 (01)00380740137380(21)AC01589 AC01591 (01)00380740137380(21)AC01591 AC01593 (01)00380740137380(21)AC01593 AC01594 (01)00380740137380(21)AC01594 AC01603 (01)00380740137380(21)AC01603 AC01604 (01)00380740137380(21)AC01604 AC01605 (01)00380740137380(21)AC01605 AC01606 (01)00380740137380(21)AC01606 AC01608 (01)00380740137380(21)AC01608 AC01630 (01)00380740137380(21)AC01630 AC01644 (01)00380740137380(21)AC01644 AC01666 (01)00380740137380(21)AC01666 AC01667 (01)00380740137380(21)AC01667 AC01668 (01)00380740137380(21)AC01668 AC01669 (01)00380740137380(21)AC01669 AC01670 (01)00380740137380(21)AC01670 AC01671 (01)00380740137380(21)AC01671 AC01672 (01)00380740137380(21)AC01672 AC01676 (01)00380740137380(21)AC01676 AC01677 (01)00380740137380(21)AC01677 AC01678 (01)00380740137380(21)AC01678 AC01679 (01)00380740137380(21)AC01679 AC01680 (01)00380740137380(21)AC01680 AC01682 (01)00380740137380(21)AC01682 AC01684 (01)00380740137380(21)AC01684 AC01702 (01)00380740137380(21)AC01702 AC01703 (01)00380740137380(21)AC01703 AC01704 (01)00380740137380(21)AC01704 AC01721 (01)00380740137380(21)AC01721 AC01731 (01)00380740137380(21)AC01731 AC01732 (01)00380740137380(21)AC01732 AC01733 (01)00380740137380(21)AC01733 AC01744 (01)00380740137380(21)AC01744 AC01746 (01)00380740137380(21)AC01746 AC01748 (01)00380740137380(21)AC01748 AC01749 (01)00380740137380(21)AC01749 AC01751 (01)00380740137380(21)AC01751 AC01752 (01)00380740137380(21)AC01752 AC01757 (01)00380740137380(21)AC01757 AC01827 (01)00380740137380(21)AC01827 AC01828 (01)00380740137380(21)AC01828 AC01829 (01)00380740137380(21)AC01829 AC01831 (01)00380740137380(21)AC01831 AC01833 (01)00380740137380(21)AC01833 AC01842 (01)00380740137380(21)AC01842 AC01843 (01)00380740137380(21)AC01843 AC01844 (01)00380740137380(21)AC01844 AC01845 (01)00380740137380(21)AC01845 AC02051 (01)00380740137380(21)AC02051 AC02052 (01)00380740137380(21)AC02052 AC02053 (01)00380740137380(21)AC02053 AC02054 (01)00380740137380(21)AC02054 AC02055 (01)00380740137380(21)AC02055 AC02056 (01)00380740137380(21)AC02056 AC02057 (01)00380740137380(21)AC02057 AC02150 (01)00380740137380(21)AC02150 AC02151 (01)00380740137380(21)AC02151 AC02152 (01)00380740137380(21)AC02152 AC02160 (01)00380740137380(21)AC02160 AC02168 (01)00380740137380(21)AC02168 AC02169 (01)00380740137380(21)AC02169 AC02170 (01)00380740137380(21)AC02170 AC02171 (01)00380740137380(21)AC02171 AC02201 (01)00380740137380(21)AC02201 AC02202 (01)00380740137380(21)AC02202 AC02203 (01)00380740137380(21)AC02203 AC02228 (01)00380740137380(21)AC02228 AC02231 (01)00380740137380(21)AC02231 AC02232 (01)00380740137380(21)AC02232 AC02234 (01)003807
Risk classification
Class II
Area (FDA)
device
Country
United States

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