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U.S. Department of Health and Human Services

Class 3 Device Recall ABX Diagnostics and Horiba

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 Class 3 Device Recall ABX Diagnostics and Horibasee related information
Date Initiated by FirmApril 15, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 24, 2004
Recall NumberZ-0992-04
Recall Event ID 29044
510(K)NumberK843962 
Product Classification Mixture, Hematology Quality Control - Product Code JPK
ProductABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials distributed by Horiba Ltd., Kyoto, Japan
Code Information Lots MX249N and MX249H of ABX Diagnostics Minotrol 16 Controls, Normal and High; and   Lots 040308ND and 040308HD of Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High.
Recalling Firm/
Manufacturer		 R & D Systems,Inc
614 Mckinley Pl Ne
Minneapolis MN 55413-2610
For Additional Information ContactRalph Hogancamp
612-656-4413
Manufacturer Reason
for Recall		Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing.
FDA Determined
Cause 2		Other
ActionRecall letters dated April 15, 2004 instructed consignees not to use the products to verify their analyzers and stated that the recalling firm is working on providing replacement products.
Quantity in Commerce29494 vials of the normal controls and 15196 of the high controls
DistributionThe products were shipped to California, France and Japan.
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 = JPK
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