# FDA recall Z-0042-2020

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2019-07-23.

## Product

Online TDM Vancomycin Gen.3 (100 tests)  Catalog # 06779336190  Analyzer/Module: cobas c 311 and cobas c 501/502

## Reason for recall

Inaccurately Low Sample Results

## Distribution

AK  AL  AR  AZ  CA  CO  CT  DC  DE  FL  GA  GU  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  PR  RI  SC  SD  TN  TX  UT  VA  VT  WA  WI  WV  WY

## Key facts

- **Recall number:** Z-0042-2020
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-23
- **Report date:** 2019-10-16
- **Termination date:** 2020-06-08

- **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-0042-2020

## Citation

> AI Analytics. FDA recall Z-0042-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0042-2020. Source: US FDA. Licensed CC0.

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