# FDA recall Z-2106-2021

> **Cell Marque Corporation** · Class II · device recall initiated 2021-05-27.

## Product

Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513

## Reason for recall

Product distributed  for use as an In-vitro Diagnostics without  FDA clearance

## Distribution

US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A

## Key facts

- **Recall number:** Z-2106-2021
- **Recalling firm:** Cell Marque Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-27
- **Report date:** 2021-07-28
- **Termination date:** 2024-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rocklin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2106-2021

## Citation

> AI Analytics. FDA recall Z-2106-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2106-2021. Source: US FDA. Licensed CC0.

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