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Recall Observatory FDA recall evidence

Device 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.

Z-0932-2021

December 22, 2020

Class III

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 87098
Status
Terminated
Classification
Class III
Quantity
10 boxes (4 units per box)
Official record key
device-enforcement:Z-0932-2021

Official wording

Reason: 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.

Code information: Lot EL629, Model 990-28011

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    incorrect concentration