# FDA recall Z-0153-2020

> **Roche Diagnostics Operations, Inc.** · Class III · device recall initiated 2019-09-11.

## Product

Cobas c Bilirubin Total Gen.3  Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

## Reason for recall

Due to low Quality Control recovery and invalid Calibration.

## Distribution

US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI.    Updated as of 12/20/19 to include the following additional US states:  CO.

## Key facts

- **Recall number:** Z-0153-2020
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-11
- **Report date:** 2019-10-23
- **Termination date:** 2024-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2020

## Citation

> AI Analytics. FDA recall Z-0153-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0153-2020. Source: US FDA. Licensed CC0.

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