# FDA recall Z-0932-2021

> **Fujifilm Medical Systems U.S.A., Inc.** · Class III · device recall initiated 2020-12-22.

## Product

Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

## Reason for recall

FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

## Distribution

US Nationwide distribution including in the states of MO, OR, MD, PA.

## Key facts

- **Recall number:** Z-0932-2021
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-22
- **Report date:** 2021-02-03
- **Termination date:** 2021-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0932-2021

## Citation

> AI Analytics. FDA recall Z-0932-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0932-2021. Source: US FDA. Licensed CC0.

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