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.
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510(K) Database | 510(K)s with Product Code = CIT
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