# K843962: CBC-PLT-4 Whole Blood Control/Multiple

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Nov 1, 1984 after 21 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K073178: HCT Extended Hematology Control, Model HCT004 (2007), 0 descendants of its own
- K061511: R&D CBC-3D + CRP Hematology Control (2006), 0 descendants of its own

## Recalls of this device
- Nov 7, 2022 · Class III · Z-0999-2023: For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
- Sep 14, 2012 · Class III · Z-0429-2013: HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communica
- Apr 15, 2004 · Not classified · Z-0992-04: 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 manufa

Source page: https://510kreport.com/device/K843962
Methodology: https://510kreport.com/methodology