# FDA recall Z-2311-2021

> **Cell Marque Corporation** · Class III · device recall initiated 2021-07-15.

## Product

Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

## Reason for recall

Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.

## Key facts

- **Recall number:** Z-2311-2021
- **Recalling firm:** Cell Marque Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-15
- **Report date:** 2021-08-25

- **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-2311-2021

## Citation

> AI Analytics. FDA recall Z-2311-2021. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-2311-2021. Source: US FDA. Licensed CC0.

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