Control Plasma N 10446235Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Assayed control used to monitor the performance of coagulation assays in the normal range · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768009174), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT A VIAL OF CONTROL PLASMA N BROKE IN THEIR HAND, CAUSING AN INJURY TO THEIR HAND. THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) AND A BAND AID WAS APPLIED TO THE INJURY. BASED ON THE HOSPITAL'S EXPOSURE PROTOCOL, THE CUSTOMER WAS ALSO TESTED FOR INFECTIOUS DISEASES, INCLUDING (B)(6) AND THE CUSTOMER WAS SCHEDULED FOR FOLLOW UP TESTING. THE CUSTOMER STATED THAT THEY WERE WEARING PERSONAL PROTECTIVE EQUIPMENT, INCLUDING GLOVES, AT THE TIME OF THE EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE BREAKAGE OF THE CONTROL PLASMA N VIAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7436077 ↗
Other PLASMA, COAGULATION CONTROL devices
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- BIOPHEN UFH Control Plasma 223101Hyphen Biomed · Plasma, Coagulation Control1 recall0 reports
- directCHECK ACT-LR Whole Blood Control, Level 2 000DCGLR-2Accriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 recall0 reports
- STA® - System Control N + P 00678Diagnostica Stago · PLASMA, COAGULATION CONTROL1 recall0 reports
- directCHECK Whole Blood Controls DCJLR-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control5 reports
- directCHECK Whole Blood Controls DCJLR-NAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control2 reports
- directCHECK Whole Blood Controls DCJCPT-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 report
- directCHECK Whole Blood Controls DCJACT-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.