ABX Diagnostics Minotrol 16 Hematology Controls, Normal and… recallZ-0992-04 · R & D Systems,Inc · initiated Apr 15, 2004
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from R & D Systems,Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0992-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 15, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- R & D Systems,Inc
- Quantity
- 29494 vials of the normal controls and 15196 of the high controls
- Product code
- JPK
- FDA submissions
- K843962
- Distribution
- The products were shipped to California, France and Japan.
Product description
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
Code information (models, lots, serial 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.
Other devices under the same FDA submission
1 device cleared under K843962 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA® 360 Control 11170853Siemens Healthcare Diagnostics Inc. · MIXTURE, HEMATOLOGY QUALITY CONTROL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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