ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; a
FDA device recall Z-0992-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- R & D Systems,Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 29494 vials of the normal controls and 15196 of the high controls
- Distribution
- The products were shipped to California, France and Japan.
- Date initiated
- 2004-04-15
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-24
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE (K843962) | R&D Systems, Inc. | 1984-11-01 |