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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multi-analyte controls, all kinds (assayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJY
Regulation Number 862.1660
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 4 4
2024 1 1
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 13 13
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Burst Container or Vessel 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Eye / Vision Problem 10 10
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 1 1
Foreign Body Sensation in Eye 1 1
Laceration(s) 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Chromsystems Instruments & Chemicals GmbH II Jul-06-2022
2 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
3 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
4 Microgenics Corporation II Oct-30-2025
5 Ortho-Clinical Diagnostics II Mar-22-2024
6 POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC III Nov-17-2025
7 Randox Laboratories Ltd. II Sep-19-2023
8 Randox Laboratories Ltd. II Aug-23-2023
9 Randox Laboratories Ltd. III Jun-28-2023
10 Randox Laboratories Ltd. II Jan-05-2023
11 TECHNO-PATH MANUFACTURING LTD. II Oct-12-2023
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