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U.S. Department of Health and Human Services

Class 3 Device Recall HDLC/LDLC Calibrator

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 Class 3 Device Recall HDLC/LDLC Calibratorsee related information
Date Initiated by FirmDecember 22, 2020
Create DateJanuary 28, 2021
Recall Status1 Terminated 3 on July 20, 2021
Recall NumberZ-0932-2021
Recall Event ID 87098
510(K)NumberK001005 
Product Classification Calibrator, primary - Product Code JIS
ProductWako 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.
Code Information Lot EL629, Model 990-28011
FEI Number 1000513161
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactJeffrey Wan
201-675-8947
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn, 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 Commerce10 boxes (4 units per box)
DistributionUS Nationwide distribution including in the states of MO, OR, MD, PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JIS
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