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U.S. Department of Health and Human Services

Class 3 Device Recall AutoHDL/LDL Cholesterol Calibrator

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 Class 3 Device Recall AutoHDL/LDL Cholesterol Calibratorsee related information
Date Initiated by FirmAugust 10, 2018
Create DateNovember 05, 2018
Recall Status1 Terminated 3 on December 04, 2019
Recall NumberZ-0389-2019
Recall Event ID 81160
510(K)NumberK992002 
Product Classification Ldl & vldl precipitation, hdl - Product Code LBR
ProductPointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Code Information Lot Number 808801-180; UDI: 00811727011411
FEI Number 1827821
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information ContactDiane Zalac
734-487-8300 Ext. 144
Manufacturer Reason
for Recall		Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
FDA Determined
Cause 2		Error in labeling
ActionNotification letters dated 8/14/18 were sent to customers. Customers were also contacted via telephone on 8/10/18. Additional letters containing labels dated 8/17/18 were sent to customers.
Quantity in Commerce22
DistributionUS Nationwide in the states of CA, FL, GA, MI, and OH.
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 = LBR
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