Recall archive / FDA device enforcement
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer al... — FDA record Z-0680-2024
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 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.
- 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
- 1,325 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0680-2024
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: 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 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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.