# FDA recall Z-2397-2019

> **Phadia Ab** · Class II · device recall initiated 2019-07-09.

## Product

Phadia" 1000  Model # 12-3800-01    Product Usage:  The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

## Reason for recall

code 7-102  Liquid Sensor Error

## Distribution

US Nationwide Distribution in the states of  CA  CO  FL  GA  HI  IL  IN  KS  KY  MA  MD  MI  MO  NC  NJ  NV  NY  OH  OK  OR  PA  TN  TX  UT  VA  WA

## Key facts

- **Recall number:** Z-2397-2019
- **Recalling firm:** Phadia Ab
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-09
- **Report date:** 2019-09-04
- **Termination date:** 2022-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Uppsala, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2397-2019

## Citation

> AI Analytics. FDA recall Z-2397-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2397-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*