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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent

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 Class 2 Device Recall Pointe Scientific Lactate Dehydrogenase (Liquid) Reagentsee related information
Date Initiated by FirmJuly 08, 2011
Date PostedMay 26, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall NumberZ-2165-2017
Recall Event ID 77048
510(K)NumberK973589 
Product Classification Nad reduction/nadh oxidation, lactate dehydrogenase - Product Code CFJ
ProductPointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Code Information L7572 all configurations
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information ContactCynthia M. Williams
734-487-8300
Manufacturer Reason
for Recall		Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website.
Quantity in Commerce716.146L total
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CFJ
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