FDAFDA · Food and drugs·Recall number Z-0680-2024
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
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: 03R65-01 Serial Numbers / UDI-DI codes (for U.S. systems only): AI01413 (01)00380740137366(21)AI01413 AI01414 (01)00380740137366(21)AI01414 AI01434 (01)00380740137366(21)AI01434 AI01447 (01)00380740137366(21)AI01447 AI01467 (01)00380740137366(21)AI01467 AI01468 (01)00380740137366(21)AI01468 AI01599 (01)00380740137366(21)AI01599 AI01607 (01)00380740137366(21)AI01607 AI01796 (01)00380740137366(21)AI01796 AI01823 (01)00380740137366(21)AI01823 AI01824 (01)00380740137366(21)AI01824 AI01827 (01)00380740137366(21)AI01827 AI01830 (01)00380740137366(21)AI01830 AI01837 (01)00380740137366(21)AI01837 AI01839 (01)00380740137366(21)AI01839 AI01873 (01)00380740137366(21)AI01873 AI01874 (01)00380740137366(21)AI01874 AI01991 (01)00380740137366(21)AI01991 AI02055 (01)00380740137366(21)AI02055 AI02056 (01)00380740137366(21)AI02056 AI02057 (01)00380740137366(21)AI02057 AI02058 (01)00380740137366(21)AI02058 AI02109 (01)00380740137366(21)AI02109 AI02110 (01)00380740137366(21)AI02110 AI02111 (01)00380740137366(21)AI02111 AI02117 (01)00380740137366(21)AI02117 AI02199 (01)00380740137366(21)AI02199 AI02201 (01)00380740137366(21)AI02201 AI02208 (01)00380740137366(21)AI02208 AI02232 (01)00380740137366(21)AI02232 AI02234 (01)00380740137366(21)AI02234 AI02288 (01)00380740137366(21)AI02288 AI02292 (01)00380740137366(21)AI02292 AI02293 (01)00380740137366(21)AI02293 AI02345 (01)00380740137366(21)AI02345 AI02368 (01)00380740137366(21)AI02368 AI02391 (01)00380740137366(21)AI02391 AI02392 (01)00380740137366(21)AI02392 AI02423 (01)00380740137366(21)AI02423 AI02433 (01)00380740137366(21)AI02433 AI02444 (01)00380740137366(21)AI02444 AI02448 (01)00380740137366(21)AI02448 AI02493 (01)00380740137366(21)AI02493 AI02514 (01)00380740137366(21)AI02514 AI02536 (01)00380740137366(21)AI02536 AI02555 (01)00380740137366(21)AI02555 AI02569 (01)00380740137366(21)AI02569 AI02592 (01)00380740137366(21)AI02592 AI02594 (01)00380740137366(21)AI02594 AI02595 (01)00380740137366(21)AI02595 AI02750 (01)00380740137366(21)AI02750 AI02784 (01)00380740137366(21)AI02784 AI02802 (01)00380740137366(21)AI02802 AI02808 (01)00380740137366(21)AI02808 AI02812 (01)00380740137366(21)AI02812 AI02821 (01)00380740137366(21)AI02821 AI02827 (01)00380740137366(21)AI02827 AI02849 (01)00380740137366(21)AI02849 AI02850 (01)00380740137366(21)AI02850 AI02859 (01)00380740137366(21)AI02859 AI02877 (01)00380740137366(21)AI02877 AI02881 (01)00380740137366(21)AI02881 AI02883 (01)00380740137366(21)AI02883 AI02894 (01)00380740137366(21)AI02894 AI02921 (01)00380740137366(21)AI02921 AI02922 (01)00380740137366(21)AI02922 AI02923 (01)00380740137366(21)AI02923 AI02939 (01)00380740137366(21)AI02939 AI02981 (01)00380740137366(21)AI02981 AI02997 (01)00380740137366(21)AI02997 AI02999 (01)00380740137366(21)AI02999 AI03007 (01)00380740137366(21)AI03007 AI03035 (01)00380740137366(21)AI03035 AI03036 (01)00380740137366(21)AI03036 AI03047 (01)00380740137366(21)AI03047 AI03060 (01)00380740137366(21)AI03060 AI03070 (01)00380740137366(21)AI03070 AI03073 (01)00380740137366(21)AI03073 AI03075 (01)00380740137366(21)AI03075 AI03077 (01)00380740137366(21)AI03077 AI03081 (01)00380740137366(21)AI03081 AI03082 (01)00380740137366(21)AI03082 AI03084 (01)00380740137366(21)AI03084 AI03085 (01)00380740137366(21)AI03085 AI03086 (01)00380740137366(21)AI03086 AI03088 (01)00380740137366(21)AI03088 AI03089 (01)00380740137366(21)AI03089 AI03093 (01)00380740137366(21)AI03093 AI03094 (01)00380740137366(21)AI03094 AI03141 (01)00380740137366(21)AI03141 AI03143 (01)00380740137366(21)AI03143 AI03145 (01)00380740137366(21)AI03145 AI03146 (01)00380740137366(21)AI03146 AI03153 (01)00380740137366(21)AI03153 AI03157 (01)00380740137366(21)AI03157 AI03160 (01)00380740137366(21)AI03160 AI03188 (01)00380740137366(21)AI03188 AI03390 (01)00380740137366(21)AI03390 AI03392 (01)00380740137366(21)AI03392 AI03393 (01)00380740137366(21)AI03393 AI03397 (01)00380740137366(21)AI03397 AI03398 (01)00380740137366(21)AI03398 AI03487 (01)00380740137366(21)AI03487 AI03498 (
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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