# FDA recall Z-1333-2021

> **Biocare Medical, LLC** · Class II · device recall initiated 2021-02-25.

## Product

BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument,  Ref: "	Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1

## Reason for recall

Their is a potential that the  automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on  random locations.

## Distribution

US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY    OUS: Germany, Netherlands

## Key facts

- **Recall number:** Z-1333-2021
- **Recalling firm:** Biocare Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-25
- **Report date:** 2021-04-07
- **Termination date:** 2023-01-31

- **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-1333-2021

## Citation

> AI Analytics. FDA recall Z-1333-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1333-2021. Source: US FDA. Licensed CC0.

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