# FDA recall Z-2242-2020

> **Beckman Coulter Inc.** · Class II · device recall initiated 2019-04-30.

## Product

Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II,  REF A32898 (UDI: 15099590202910)  for use with the Access Family of Immunoassay Systems including:  Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.

## Reason for recall

The recalling firm characterized the potential interference effects of  biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860,  and TgAbII-REF A32898 displayed significant interference (defined as  a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

## Distribution

US Distribution:  Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusett, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico  New York, North Carolina, North Dakota, Ohio, Oklahoma  Oregon, Pennsylvania, Rhode Island, South Carolina,South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.  US  Territories: American Samoa, Guam, and Puerto Rico.    OUS Distribution:  Algeria,  Andorra, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Guyana, Hong Kon

## Key facts

- **Recall number:** Z-2242-2020
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-30
- **Report date:** 2020-06-10
- **Termination date:** 2021-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2242-2020

## Citation

> AI Analytics. FDA recall Z-2242-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2242-2020. Source: US FDA. Licensed CC0.

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