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
- Company
- R & D Systems, Inc.
- Recall Initiated
- April 15, 2004
- Posted
- July 20, 2004
- Terminated
- June 24, 2004
- Recall Number
- Z-0992-04
- Quantity
- 29494 vials of the normal controls and 15196 of the high controls
- Firm Location
- Minneapolis, MN
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.
Distribution
The products were shipped to California, France and Japan.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.
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