# FDA recall Z-0680-2024

> **Abbott Laboratories** · Class II · device recall initiated 2023-10-19.

## 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).

## 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

## Key facts

- **Recall number:** Z-0680-2024
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-19
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0680-2024

## Citation

> AI Analytics. FDA recall Z-0680-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0680-2024. Source: US FDA. Licensed CC0.

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