TPLC - Total Product Life Cycle

• Device: multi-analyte controls, all kinds (assayed)
• Product Code: JJY
• Regulation Number: 862.1660
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	1	1
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	8	8
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
No Consequences Or Impact To Patient	8	8
No Clinical Signs, Symptoms or Conditions	2	2
Foreign Body Sensation in Eye	1	1
Needle Stick/Puncture	1	1
Insufficient Information	1	1
Laceration(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	III	May-16-2019
2	Chromsystems Instruments & Chemicals GmbH	II	Jul-06-2022
3	Chromsystems Instruments & Chemicals GmbH	II	Dec-04-2020
4	Chromsystems Instruments & Chemicals GmbH	II	Dec-02-2020
5	Helena Laboratories, Inc.	II	Aug-30-2019
6	Mckesson Medical-Surgical Inc. Corporate Office	II	Mar-19-2024
7	Medline Industries Inc	II	Sep-30-2020
8	Ortho Clinical Diagnostics Inc	III	Nov-18-2020
9	Ortho-Clinical Diagnostics	II	Mar-22-2024
10	Randox Laboratories Ltd.	II	Sep-19-2023
11	Randox Laboratories Ltd.	II	Aug-23-2023
12	Randox Laboratories Ltd.	III	Jun-28-2023
13	Randox Laboratories Ltd.	II	Jan-05-2023
14	Randox Laboratories Ltd.	II	Mar-20-2020
15	Randox Laboratories Ltd.	III	Feb-06-2020
16	Randox Laboratories Ltd.	II	Jun-14-2019
17	Randox Laboratories Ltd.	III	Apr-08-2019
18	Randox Laboratories Ltd.	II	Mar-26-2019
19	Randox Laboratories, Limited	II	Nov-15-2019
20	Randox Laboratories, Limited	III	Aug-07-2019
21	Randox Laboratories, Limited	II	Aug-06-2019
22	Response Biomedical Corp.	II	Mar-10-2020
23	TECHNO-PATH MANUFACTURING LTD.	II	Oct-12-2023
24	Utak Laboratories Inc	III	Jun-22-2020