# FDA recall Z-2043-2023

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2023-05-17.

## Product

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

## Reason for recall

Reagent lot numbers include an insufficient concentration of blocking reagent.

## Distribution

Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA.  There was government distribution but no military distribution.  Foreign distribution was made to Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, and Vietnam.

## Key facts

- **Recall number:** Z-2043-2023
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-17
- **Report date:** 2023-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2043-2023

## Citation

> AI Analytics. FDA recall Z-2043-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2043-2023. Source: US FDA. Licensed CC0.

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