Z-0932-2021 Class III Terminated
FDA device recall Z-0932-2021 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Dec 22, 2020 and is designated Class III. 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… The recall status is terminated (terminated Jul 20, 2021). Affected quantity: 10 boxes (4 units per box).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 3, 2021
- Initiation Date
- Dec 22, 2020
- Termination Date
- Jul 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 boxes (4 units per box)
Product Description
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 Pattern
US Nationwide distribution including in the states of MO, OR, MD, PA.
Code Information
Lot EL629, Model 990-28011
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0932-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026