# FDA recall Z-0681-2024

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

## Product

Alinity c Processing Module REF 03R67-01      The Alinity c Processing Module is a fully automated chemistry analyzer allowing random  and continuous access, as well as priority and automated retest processing using  photometric and potentiometric detection technology. The Alinity c Processing Module  uses photometric detection technology to measure sample absorbance for the  quantification of analyte concentration and uses potentiometric detection technology to  measure the electrical potential in a sample. In addition, the Alinity c Processing Module  uses an integrated chip technology (ICT) module to measure potentiometric assays  (electrolytes).

## 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-0681-2024
- **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-0681-2024

## Citation

> AI Analytics. FDA recall Z-0681-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0681-2024. Source: US FDA. Licensed CC0.

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