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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)
Product CodeJJY
Regulation Number 862.1660
Device Class 1

MDR Year MDR Reports MDR Events
2018 7 7
2019 1 1
2020 7 7
2021 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 10 10
Improper or Incorrect Procedure or Method 3 3
Nonstandard Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Use of Device Problem 1 1
Burst Container or Vessel 1 1
High Test Results 1 1
Defective Device 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 3 3
Needle Stick/Puncture 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Laceration(s) 1 1
No Information 1 1
Insufficient Information 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 Medline Industries Inc II Sep-30-2020
7 Ortho Clinical Diagnostics Inc III Nov-18-2020
8 Ortho Clinical Diagnostics Inc III Mar-01-2018
9 Randox Laboratories III Mar-12-2018
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 Ltd. II Nov-03-2018
20 Randox Laboratories Ltd. II Jul-30-2018
21 Randox Laboratories Ltd. II Jun-13-2018
22 Randox Laboratories, Limited II Nov-15-2019
23 Randox Laboratories, Limited III Aug-07-2019
24 Randox Laboratories, Limited II Aug-06-2019
25 Randox Laboratories, Limited II Mar-09-2018
26 Response Biomedical Corp. II Mar-10-2020
27 TECHNO-PATH MANUFACTURING LTD. II Oct-12-2023
28 Tosoh Bioscience Inc II May-14-2018
29 Utak Laboratories Inc III Jun-22-2020
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