R & D Systems, Inc ABX 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABX 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
Brand
R & D Systems, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
R & D Systems, Inc is recalling ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagno due to Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Recall 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026