FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0992-04
- 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
- Status
- Terminated
- Initiated
- 2004-04-15
- Posted
- 2004-07-20
- Terminated
- 2004-06-24
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K843962"]
- PMA numbers
- not on file
- Product code
- JPK
- Firm FEI
- 2182501
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28