TPLC - Total Product Life Cycle

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Device	activated whole blood clotting time
Regulation Description	Activated whole blood clotting time tests.
Product Code	JBP
Regulation Number	864.7140
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	76	76
Adverse Event Without Identified Device or Use Problem	2	2
Break	1	1
Off-Label Use	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
Chest Pain	11	11
Pain	5	5
Myocardial Infarction	4	4
High Blood Pressure/ Hypertension	2	2
No Information	2	2
Ischemic Heart Disease	2	2
Angina	2	2
Heart Failure/Congestive Heart Failure	2	2
Decreased Respiratory Rate	2	2
Respiratory Distress	1	1
No Code Available	1	1
Nausea	1	1
Ventricular Tachycardia	1	1
Dizziness	1	1
Diabetic Ketoacidosis	1	1
Coagulation Disorder	1	1
Atrial Fibrillation	1	1
Cellulitis	1	1
Transient Ischemic Attack	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Exposure to Body Fluids	1	1
Dyspnea	1	1
Hyperglycemia	1	1
Laceration(s)	1	1
Cardiomyopathy	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Swelling/ Edema	1	1
Hemorrhage/Bleeding	1	1
Cardiac Enzyme Elevation	1	1
ST Segment Elevation	1	1
Aortic Valve Stenosis	1	1
Pulmonary Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Accriva Diagnostics, Inc.	II	Dec-03-2025
2	Medtronic Perfusion Systems	II	Nov-18-2025