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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
2020 7 7
2021 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 7 7
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
High Test Results 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 2 2
Laceration(s) 1 1
Insufficient Information 1 1
Foreign Body Sensation in Eye 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Chromsystems Instruments & Chemicals GmbH II Jul-06-2022
2 Chromsystems Instruments & Chemicals GmbH II Dec-04-2020
3 Chromsystems Instruments & Chemicals GmbH II Dec-02-2020
4 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
5 Medline Industries Inc II Sep-30-2020
6 Ortho Clinical Diagnostics Inc III Nov-18-2020
7 Ortho-Clinical Diagnostics II Mar-22-2024
8 Randox Laboratories Ltd. II Sep-19-2023
9 Randox Laboratories Ltd. II Aug-23-2023
10 Randox Laboratories Ltd. III Jun-28-2023
11 Randox Laboratories Ltd. II Jan-05-2023
12 Randox Laboratories Ltd. II Mar-20-2020
13 Randox Laboratories Ltd. III Feb-06-2020
14 Response Biomedical Corp. II Mar-10-2020
15 TECHNO-PATH MANUFACTURING LTD. II Oct-12-2023
16 Utak Laboratories Inc III Jun-22-2020
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