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.
FDA Recall Z-0932-2021 · Posted None
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Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeJIS
Date Initiated2020-12-22
Date Terminated2021-07-20
Product Quantity10 boxes (4 units per box)
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the states of MO, OR, MD, PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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