openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
These labels are deterministic app interpretations, not FDA categories.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
Code information
UDI: (01)15099590681555/ All serial numbers
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.
device · product 2 of 3
PE Centrifuge, REF: B36365, a component of the Power Express
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
These labels are deterministic app interpretations, not FDA categories.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
Code information
UDI: (01)15099590673550/ All serial numbers Lots
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.
device · product 3 of 3
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
These labels are deterministic app interpretations, not FDA categories.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
Code information
UDI: (01)15099590673567/ All serial numbers
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.
