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
FDA Recall Z-0992-04 · Posted 2004-07-20
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Recalling FirmR & D Systems,Inc
Recall StatusTerminated
Product CodeJPK
Date Initiated2004-04-15
Date Terminated2004-06-24
Product Quantity29494 vials of the normal controls and 15196 of the high controls
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The products were shipped to California, France and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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