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U.S. Department of Health and Human Services

Class 2 Device Recall RF Latex Reagent

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  Class 2 Device Recall RF Latex Reagent see related information
Date Initiated by Firm February 13, 2018
Create Date March 15, 2018
Recall Status1 Terminated 3 on September 27, 2018
Recall Number Z-1070-2018
Recall Event ID 79245
510(K)Number K974370  
Product Classification System, test, rheumatoid factor - Product Code DHR
Product RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30)
RF Latex (1156-001, Control# 172224 expiry 2019-12-31)
RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31)

Product Usage:
RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
Code Information Lot 21675
Recalling Firm/
Manufacturer		 Stanbio Laboratory, LP
1261 N Main St
Boerne TX 78006-3014
Manufacturer Reason
for Recall		 All patient serum samples yield a weakly positive test result.
FDA Determined
Cause 2		 Component design/selection
Action Recall notification letters were sent to affected consignees on 2/14/2018. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to stop using affected products, quarantine products, and exchange the kit for an unaffected one.
Quantity in Commerce 686 units
Distribution Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
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 = DHR and Original Applicant = STANBIO LABORATORY
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