Recall archive / FDA device enforcement
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allo... — FDA record Z-0681-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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).
- Reason
- The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
- Classification
- Class II
- Recalling firm
- Abbott Laboratories
- Quantity
- 1,127 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0681-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 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(01)00380740137380(21)AC02564 AC02565 (01)00380740137380(21)AC02565 AC02566 (01)00380740137380(21)AC02566 AC02567 (01)00380740137380(21)AC02567 AC02568 (01)00380740137380(21)AC02568 AC02569 (01)00380740137380(21)AC02569 AC02570 (01)00380740137380(21)AC02570 AC02571 (01)00380740137380(21)AC02571 AC02572 (01)00380740137380(21)AC02572 AC02573 (01)00380740137380(21)AC02573 AC02574 (01)00380740137380(21)AC02574 AC02575 (01)00380740137380(21)AC02575 AC02576 (01)00380740137380(21)AC02576 AC02577 (01)00380740137380(21)AC02577 AC02578 (01)00380740137380(21)AC02578 AC02579 (01)00380740137380(21)AC02579 AC02580 (01)00380740137380(21)AC02580 AC02581 (01)00380740137380(21)AC02581 AC02583 (01)00380740137380(21)AC02583 AC02584 (01)00380740137380(21)AC02584 AC02585 (01)00380740137380(21)AC02585 AC02586 (01)00380740137380(21)AC02586 AC02587 (01)00380740137380(21)AC02587 AC02588 (01)00380740137380(21)AC02588 AC02589 (01)00380740137380(21)AC02589 AC02590 (01)00380740137380(21)AC02590 AC02591 (01)00380740137380(21)AC02591 AC02594 (01)00380740137380(21)AC02594 AC02602 (01)00380740137380(21)AC02602 AC02606 (01)00380740137380(21)AC02606 AC02610 (01)00380740137380(21)AC02610 AC02611 (01)00380740137380(21)AC02611 AC02612 (01)00380740137380(21)AC02612 AC02613 (01)00380740137380(21)AC02613 AC02614 (01)00380740137380(21)AC02614 AC02658 (01)00380740137380(21)AC02658 AC02659 (01)00380740137380(21)AC02659 AC02660 (01)00380740137380(21)AC02660 AC02661 (01)00380740137380(21)AC02661 AC02662 (01)00380740137380(21)AC02662 AC02663 (01)00380740137380(21)AC02663 AC02664 (01)00380740137380(21)AC02664 AC02665 (01)00380740137380(21)AC02665 AC02666 (01)00380740137380(21)AC02666 AC02667 (01)00380740137380(21)AC02667 AC02668 (01)00380740137380(21)AC02668 AC02670 (01)00380740137380(21)AC02670 AC02671 (01)00380740137380(21)AC02671 AC02672 (01)00380740137380(21)AC02672 AC02673 (01)00380740137380(21)AC02673 AC02674 (01)00380740137380(21)AC02674 AC02687 (01)00380740137380(21)AC02687 AC02688 (01)00380740137380(21)AC02688 AC02689 (01)00380740137380(21)AC02689 AC02690 (01)00380740137380(21)AC02690 AC02691 (01)00380740137380(21)AC02691 AC02692 (01)00380740137380(21)AC02692 AC02693 (01)00380740137380(21)AC02693 AC02694 (01)00380740137380(21)AC02694 AC02695 (01)00380740137380(21)AC02695 AC02696 (01)00380740137380(21)AC02696 AC02697 (01)00380740137380(21)AC02697 AC02699 (01)00380740137380(21)AC02699 AC02700 (01)00380740137380(21)AC02700 AC02704 (01)00380740137380(21)AC02704 AC02705 (01)00380740137380(21)AC02705 AC02707 (01)00380740137380(21)AC02707 AC02708 (01)00380740137380(21)AC02708 AC02710 (01)00380740137380(21)AC02710 AC02711 (01)00380740137380(21)AC02711 AC02712 (01)00380740137380(21)AC02712 AC02713 (01)00380740137380(21)AC02713 AC02714 (01)00380740137380(21)AC02714 AC02715 (01)00380740137380(21)AC02715 AC02716 (01)00380740137380(21)AC02716 AC02717 (01)00380740137380(21)AC02717 AC02718 (01)00380740137380(21)AC02718 AC02719 (01)00380740137380(21)AC02719 AC02720 (01)00380740137380(21)AC02720 AC02721 (01)00380740137380(21)AC02721 AC02722 (01)00380740137380(21)AC02722 AC02723 (01)00380740137380(21)AC02723 AC02724 (01)00380740137380(21)AC02724 AC02725 (01)00380740137380(21)AC02725 AC02726 (01)00380740137380(21)AC02726 AC02727 (01)00380740137380(21)AC02727 AC02730 (01)00380740137380(21)AC02730 AC02731 (01)00380740137380(21)AC02731 AC02732 (01)00380740137380(21)AC02732 AC02733 (01)00380740137380(21)AC02733 AC02734 (01)00380740137380(21)AC02734 AC02735 (01)00380740137380(21)AC02735 AC02736 (01)00380740137380(21)AC02736 AC02737 (01)00380740137380(21)AC02737 AC02738 (01)00380740137380(21)AC02738 AC02739 (01)00380740137380(21)AC02739 AC02746 (01)00380740137380(21)AC02746 AC02747 (01)00380740137380(21)AC02747 AC02748 (01)00380740137380(21)AC02748 AC02749 (01)00380740137380(21)AC02749 AC02750 (01)00380740137380(21)AC02750 AC02759 (01)00380740137380(21)AC02759 AC02760 (01)00380740137380(21)AC02760 AC02761 (01)00380740137380(21)AC02761 AC02762 (01)00380740137380(21)AC02762 AC02764 (01)00380740137380(21)AC02764 AC02765 (01)00380740137380(21)AC02765 AC02770 (01)00380740137380(21)AC02770 AC02771 (01)00380740137380(21)AC02771 AC02772 (01)00380740137380(21)AC02772 AC02773 (01)00380740137380(21)AC02773 AC02778 (01)00380740137380(21)AC02778 AC02780 (01)00380740137380(21)AC02780 AC02784 (01)00380740137380(21)AC02784 AC02786 (01)00380740137380(21)AC02786 AC02788 (01)00380740137380(21)AC02788 AC02789 (01)00380740137380(21)AC02789 AC02791 (01)00380740137380(21)AC02791 AC02792 (01)00380740137380(21)AC02792 AC02793 (01)00380740137380(21)AC02793 AC02794 (01)00380740137380(21)AC02794 AC02797 (01)00380740137380(21)AC02797 AC02799 (01)00380740137380(21)AC02799 AC02800 (01)00380740137380(21)AC02800 AC02801 (01)00380740137380(21)AC02801 AC02802 (01)00380740137380(21)AC02802 AC02803 (01)00380740137380(21)AC02803 AC02804 (01)00380740137380(21)AC02804 AC02805 (01)00380740137380(21)AC02805 AC02807 (01)00380740137380(21)AC02807 AC02808 (01)00380740137380(21)AC02808 AC02810 (01)00380740137380(21)AC02810 AC02811 (01)00380740137380(21)AC02811 AC02812 (01)00380740137380(21)AC02812 AC02814 (01)00380740137380(21)AC028... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
Dates in the source
- Report date
- Jan 17, 2024
- Recall initiation date
- Oct 19, 2023
- Center classification date
- Jan 8, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.