Z-0932-2021Class III

Wako HDL-C/LDL-C Calibrator -

Name: Z-0932-2021 Wako HDL-C/LDL-C Calibrator -
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2020-12-22
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2020-12-22 / Terminated / root cause: labeling and UDI

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of 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... on 2020-12-22. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0932-2021
Classification: Class III
Status: Terminated
Initiated: 2020-12-22
Posted: 2021-01-28
Terminated: 2021-07-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
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.
Product code: JIS Calibrator, Primary
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On, 12/22/2020, FUJIFILM issued an Urgent Medical Device Removal notice to customers via email. Incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result in incorrect results when used in testing.
Quantity in commerce: 10 boxes (4 units per box)
Distribution: US Nationwide distribution including in the states of MO, OR, MD, PA.
Product codes and lots: Lot EL629, Model 990-28011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0932-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0932-2021	Class III	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-28

Product code JIS

K001005Class IIWako Hdl-C/ldl-C CalibratorWako Chemicals USA, Inc. / cleared 2000-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)