# FDA recall Z-1607-2023

> **Beckman Coulter Inc.** · Class II · device recall initiated 2023-04-05.

## Product

Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL

## Reason for recall

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality  control failures.

## Distribution

Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC,	DE, FL, GA, HI,	IA,	ID,	IL,	IN,	KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV,	NY,	OH, OK, OR, PA, RI, SC, SD, TN,	TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,

## Key facts

- **Recall number:** Z-1607-2023
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-05
- **Report date:** 2023-05-24

- **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-1607-2023

## Citation

> AI Analytics. FDA recall Z-1607-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1607-2023. Source: US FDA. Licensed CC0.

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