Alinity i Processing Module REF 03R65-01 The Alinity i Processing… — Class II medical device recall Z-0680-2024

Ongoing recall by Abbott Laboratories, reported 2024-01-17, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural

Recall number	`Z-0680-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Abbott Laboratories, Irving, TX, United States
Recall initiated	2023-10-19
Classified	2024-01-08
Reported by FDA	2024-01-17
Distributed	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
Countries outside the US	BR
Quantity	1,325 systems
Reason classes	labeling
UPC / GTIN / UDI-DI	`00380740137366`
Model numbers	`03R65-01`

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0680-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.