Stak-Chex Plus Retics

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K992887 ↗

FDA Product Code

GLQ

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Para 12 Plus

  Class II

  FDA 510(k) K901875 Active Cleared 30 May 1990

• Para 12 Plus Retics

  Class II

  CE/IVDR FDA 510(k) K000945 Active Cleared 18 Apr 2000

• Retic Chex Linearity

  Class II

  FDA 510(k) K000115 Active Cleared 27 Mar 2000

• Platelet-Chex-Human

  Class II

  FDA 510(k) K770020 Active Cleared 16 Feb 1977

• Cal-Chex Cd Plus

  Class II

  FDA 510(k) K020469 Active Cleared 4 Apr 2002

• Chem-Chex Stat

  Class I

  FDA 510(k) K961195 Active Cleared 15 May 1996

See all devices from Streck Laboratories, Inc. →

• What is the Stak-Chex Plus Retics used for in a clinical lab?

  The Stak-Chex Plus Retics is a multi-level stacked control designed specifically for hematology analyzers. It provides standardized reference values for white blood cell differential counts, reticulocytes, and nucleated red blood cells. This helps ensure the accuracy and reliability of automated hematology instruments, supporting quality control protocols in clinical laboratories.

• How is the Stak-Chex Plus Retics supplied, and what levels are included?

  The Stak-Chex Plus Retics is supplied as a whole blood-based control in three distinct levels: low, normal, and high. These levels allow laboratories to monitor and verify the performance of their hematology analyzers across a range of expected results, ensuring consistent and accurate testing.

• Is the Stak-Chex Plus Retics intended for single-use or reuse?

  The Stak-Chex Plus Retics is designed for single-use in clinical laboratories. Like most liquid-based controls, it is meant to be used once per vial to maintain accuracy and prevent contamination, adhering to standard laboratory practices for quality control.

• What type of hematology analyzers is the Stak-Chex Plus Retics compatible with?

  The Stak-Chex Plus Retics is primarily intended for use with hematology analyzers compatible with Beckman Coulter instruments. The vials feature pierceable caps, ensuring seamless integration with automated sampling systems, which simplifies workflow and enhances usability.

• How should the Stak-Chex Plus Retics be stored and handled?

  The Stak-Chex Plus Retics should be stored and handled according to standard laboratory practices for liquid-based controls. This includes maintaining appropriate temperature conditions, avoiding exposure to extreme temperatures or light, and ensuring proper sealing to prevent contamination. Always follow manufacturer guidelines for optimal performance and shelf life.