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U.S. Department of Health and Human Services

Class 3 Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent

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  Class 3 Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent see related information
Date Initiated by Firm March 13, 2015
Date Posted September 14, 2015
Recall Status1 Terminated 3 on October 29, 2015
Recall Number Z-2764-2015
Recall Event ID 71953
510(K)Number K992002  
Product Classification Ldl & vldl precipitation, hdl - Product Code LBR
Product Pointe Scientific autoHDL Reagent H7545

H7545-R1 in a bulk cube container or HDPE plastic bottle
H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2
12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2
HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2

Kits: HDPE plastic bottle, PP plastic caps.
Bulk: PE plastic cube containers, PP plastic caps.

Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
Code Information Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Customer Support
800-445-9853
Manufacturer Reason
for Recall		 Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Pointe Scientific sent a Field Correction Notice on March 13, 2015, to all affected customers via fax, email, and mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Technical Service Department at 1-800-757-5313.
Quantity in Commerce H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits
Distribution Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
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 = LBR and Original Applicant = POINTE SCIENTIFIC, INC.
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