# FDA recall Z-1752-2020

> **Beckman Coulter Inc.** · Class II · device recall initiated 2019-09-04.

## Product

Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

## Reason for recall

Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of  certain compounds in urine may result in false positive or false negative patient test results.

## Distribution

Distributed throughout  the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY.

## Key facts

- **Recall number:** Z-1752-2020
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-04
- **Report date:** 2020-04-29
- **Termination date:** 2021-04-28

- **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-1752-2020

## Citation

> AI Analytics. FDA recall Z-1752-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1752-2020. Source: US FDA. Licensed CC0.

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