Control Plasma P 10446472Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Assayed control used to monitor the performance of coagulation assays in the pathological 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 00842768011580), received between Mar 26, 2021 and Mar 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER CUT THEIR THUMB DUE TO A CONTROL PLASMA P BOTTLE THAT BROKE DURING RECONSTITUTION. THE GLASS OF THE BOTTLE CUT THEIR THUMB AS THEY WERE OPENING THE BOTTLE. THE CUT REQUIRED ANTISEPTIC AND A BANDAGE. THE CUSTOMER HAS FOLLOWED THE SITE'S EXPOSURE PROTOCOLS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574856 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.