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U.S. Department of Health and Human Services

Class 3 Device Recall Pointe Scientific Hitachi AST Reagent

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  Class 3 Device Recall Pointe Scientific Hitachi AST Reagent see related information
Date Initiated by Firm February 15, 2012
Date Posted May 18, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-2116-2017
Recall Event ID 76985
510(K)Number K941132  
Product Classification Nadh oxidation/nad reduction, ast/sgot - Product Code CIT
Product Pointe Scientific Hitachi AST Reagent

R1 : PE plastic bottle w/PP plastic cap.
R2: PE plastic bottle w /PP plastic cap.

Product Usage:
Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Code Information Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Cynthia M. Williams
734-487-8300
Manufacturer Reason
for Recall		 A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
FDA Determined
Cause 2		 Error in labeling
Action Technical Bulletin Notification letter was sent 02/15/12 by email to all customers and distributors. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-757-5313.
Quantity in Commerce 119.168L across All lots
Distribution US Nationwide Distribution
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 = CIT and Original Applicant = POINTE SCIENTIFIC, INC.
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