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U.S. Department of Health and Human Services

Class 2 Device Recall IVD calibrator

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  Class 2 Device Recall IVD calibrator see related information
Date Initiated by Firm May 01, 2009
Date Posted March 04, 2010
Recall Status1 Terminated 3 on January 21, 2011
Recall Number Z-0973-2010
Recall Event ID 53750
510(K)Number K023828  
Product Classification C-reactive protein, antigen, antiserum, and control - Product Code DCK
Product "K-ASSAY CRP (3) Calibrator E".


This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.
Code Information Catalog number: "KAI-084C", Lot # "559011"
Recalling Firm/
Manufacturer		 Kamiya Biomedical Company, LLC
12779 Gateway Dr S
Tukwila WA 98168-3308
For Additional Information Contact
206-575-8068
Manufacturer Reason
for Recall		 The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.
FDA Determined
Cause 2		 Other
Action On May 1, 2009 the recalling firm, Kamiya Biomedical Company contacted the 3 consignees by telephone and notified them of the issue. A follow-up e-mail notification on May 4, 2009 was sent to consignees requesting to return the affected product to Kamiya Biomedical Company for a free replacement kit. After the e-mail notifications, an Urgent Medical Device Recall Notice dated May 13, 2009 was also sent to consignees describing the issue and actions to take for returning opened and unopened affected product to the recalling firm for replacement. Direct questions to the Kamiya Biomedical Company by calling 1- 206-575-8068.
Quantity in Commerce 3 kits each containing 5 x 2 ml vials
Distribution United States (NY, NJ, and NC).
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 = DCK and Original Applicant = KAMIYA BIOMEDICAL CO.
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