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
|