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Open, Classified

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.

FDA Recall Z-0680-2024 · Posted 2024-01-09

Recalling FirmAbbott Laboratories
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2023-10-19
Product Quantity1,325 systems

Reason for Recall

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

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 contain dry natural rubber (latex) which may cause allergic reactions, but do not include the required precautionary label. Additionally, the Alinity s System Solid Waste Container Rubber Band (LN 04U97-01), used to secure the biohazard bag to the solid waste container, contains dry natural rubber (latex). Customer are instructed to: 1) Follow good laboratory practice by wearing impervious gloves and other personal protective equipment when working on the above listed Abbott product(s). 2) If you have forwarded the product(s) listed above to other laboratories, please inform them of this Product Correction and provide a copy of this letter. 3) Please retain this letter for your laboratory records. A precautionary label will be applied to the affected products. An Abbott representative will schedule a service visit when the instrument label is available for application. For questions or concerns, contact Customer Service at 1-877-4ABBOTT (24 hr/7 days a week).

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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