FDA Device recall Z-0680-2024
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and cont…
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and cont… by Abbott Laboratories, citing the devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0680-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-19 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Laboratories |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
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).
Identifiers
| code_info | List Number: 03R65-01 Serial Numbers / UDI-DI codes (for U.S. systems only): AI01413 (01)00380740137366(21)AI01413 AI01…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Abbott Laboratories
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FDA Device · Class II · 2025-04-30 · Abbott Laboratories - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories
All Abbott Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0680-2024%22
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