HemosIL RecombiPlasTin 2G (20 mL) 00020003050Recalls & reported problems
Instrumentation Laboratory Company · HemosIL RecombiPlasTin 2G (20 mL) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08426950447627), received between Feb 2, 2024 and Feb 2, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
1 other recall cover devices cleared under the same FDA submission (K070005); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2024Crack; Crack
IT WAS REPORTED THAT A VIAL BROKE WHILE THE LAB TECHNICIAN TRIED TO OPEN IT AND CAUSED AN INJURY.
Patient problems: Laceration(s)
MAUDE report 18629808 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K070005. One submission often covers many models, so check the product and lot details in each record.
- Z-1784-2013 · Apr 9, 2013 · TerminatedHemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant
Other TEST, TIME, PROTHROMBIN devices
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- CoaguChek XS Patient Self Testing Care Kit 03666794001Roche Diagnostics GmbH · Test, Time, Prothrombin212 reports
- CoaguChek XS Patient Self Testing Care Kit 4837738001Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN134 reports
- i-STAT 03P89-24Abbott Point Of Care Inc. · TEST, TIME, PROTHROMBIN127 reports
- HemosIL ReadiPlasTin (20 mL) 00020301400Instrumentation Laboratory Company · TEST, TIME, PROTHROMBIN2 recalls2 reports
- STA® - Néoplastine® CI 10 00666Diagnostica Stago · TEST, TIME, PROTHROMBIN1 recall0 reports
- Coag-Sense Test Strip Kit, 50 ct. 100218Coagusense Inc. · Test, Time, Prothrombin1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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