# FDA recall Z-2291-2020

> **Biocare Medical, LLC** · Class II · device recall initiated 2019-10-10.

## Product

4plus Streptavidin HRP Label,  Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H

## Reason for recall

Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.

## Distribution

US: TX, MA, TN, MO, IN

## Key facts

- **Recall number:** Z-2291-2020
- **Recalling firm:** Biocare Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-10
- **Report date:** 2020-06-17
- **Termination date:** 2020-12-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2020

## Citation

> AI Analytics. FDA recall Z-2291-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2291-2020. Source: US FDA. Licensed CC0.

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