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Para Tech Plus Retics

by Streck Laboratories, Inc.

510(k) K993825

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993825 Date30 Nov 1999ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2089-2025 FDA Class II initiated 4 Jun 2025
    • Ongoing Z-2088-2025 FDA Class II initiated 4 Jun 2025
    • Ongoing Z-2087-2025 FDA Class II initiated 4 Jun 2025

    Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JCN
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Para Tech Plus Retics is an assayed hematology control used to validate the performance of Bayer Advia 120 and Technicon H-Series hematology instruments. The device consists of a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes.

The device is supplied as a single-use control and is intended for use in hematology laboratories. It is not sterilized and should be stored according to the manufacturer's instructions. The device is regulated as a Class II medical device under FDA 510(k) clearance.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Para Tech Plus Retics used for?

    Para Tech Plus Retics is an assayed hematology control designed to validate the performance of Bayer Advia 120 and Technicon H-Series hematology instruments.

  • What is the device made of?

    The device is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes.

  • Is the device sterile and single-use?

    No, the device is not sterilized and is supplied as a single-use control for use in hematology laboratories.

  • How should the device be stored?

    The device should be stored according to the manufacturer's instructions.

  • What is the regulatory status of this device?

    Para Tech Plus Retics is a Class II medical device regulated under FDA 510(k) clearance.