Recall Z-0682-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
| 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 | 995 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.