Recall Z-0680-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories
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.
| Date | Jan 9, 2024 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). |
| Root cause | Under Investigation by firm |
| Action | On 10/19/2023, the firm sent an "Urgent Medical Device Correction" Letter via FedEx priority overnight express to customers informing them that Abbott has determined that, A labeling update is required for the products listed above to meet US regulatory requirement 21 CFR 801.437 (User labeling for devices that contain natural rubber) and Brazilian requirement RDC 37/2015 (medical devices and IVDs to include in the label a Standardized Latex Warning in Portuguese CONTAIN NATURAL LATEX. MAY CAUSE ALLERGIES ). These Abbott products include internal hardware parts and/or subassemblies that conta |
| Quantity | 1,325 systems |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.