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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 Calibrator see related information
Date Initiated by Firm December 22, 2020
Create Date January 28, 2021
Recall Status1 Terminated 3 on July 20, 2021
Recall Number Z-0932-2021
Recall Event ID 87098
510(K)Number K001005  
Product Classification Calibrator, primary - Product Code JIS
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.
Code Information Lot EL629, Model 990-28011
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact Jeffrey 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JIS and Original Applicant = WAKO CHEMICALS, USA, INC.
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