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U.S. Department of Health and Human Services

Class 3 Device Recall KASSAY

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 Class 3 Device Recall KASSAYsee related information
Date Initiated by FirmApril 11, 2006
Date PostedMay 06, 2006
Recall Status1 Terminated 3 on May 16, 2006
Recall NumberZ-0850-06
Recall Event ID 35169
510(K)NumberK992312 
Product Classification C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
ProductK-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.
Code Information Lot No.: 666011 EXP.: 07/2007
Recalling Firm/
Manufacturer		 Kamiya Biomedical Company
12779 Gateway Dr.
Seattle WA 98168
For Additional Information ContactColin Getty
206-575-8068 Ext. 105
Manufacturer Reason
for Recall		Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent
FDA Determined
Cause 2		Other
ActionCustomers were contacted via telephone on 4/11/06. Customers were asked to confirm the number of kits in their possession and then open the kits to verify which vials they received in their kits. If the kits contained both vials, then the customer was instructed to keep the kit. If the kits contained the wrong vials, then they were requested to return the kits. This was followed by a letter dated 4/17/06. The letter confirmed the telephone call and asked the customer to sign and return the letter to acknoweldge receipt of the letter.
Quantity in Commerce185 kits
DistributionKits were distributed to laboratories nationwide. One foreign account in Singapore.
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 = DCK
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