Recall Z-0992-04 ยท JPK Mixture, Hematology Quality Control
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
| Date | Jul 20, 2004 (initiated Apr 15, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 29494 vials of the normal controls and 15196 of the high controls |
| Distribution | The products were shipped to California, France and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843962 | CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE R&D Systems, Inc., Nov 1, 1984 |