Z-0992-04

ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics...

Name: Z-0992-04 ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics...
Creator: R & D Systems,Inc
Published: 2004-04-15
License: https://open.fda.gov/license/

R & D Systems, Inc. / initiated 2004-04-15 / Terminated / root cause: manufacturing process

FDA source

R & D Systems,Inc began a recall of ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology... on 2004-04-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0992-04
Status: Terminated
Initiated: 2004-04-15
Posted: 2004-07-20
Terminated: 2004-06-24
Recalling firm: R & D Systems, Inc.
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
Product code: JPK Mixture, Hematology Quality Control
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 29494 vials of the normal controls and 15196 of the high controls
Distribution: The products were shipped to California, France and Japan.
Product codes and lots: 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.

Product code JPK

K843962Class IICbc-Plt-4 Whole Blood Control/multipleR&D Systems, Inc. / cleared 1984-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)