HemosIL ReadiPlasTin (20 mL) 00020301400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08426950632887), received between Feb 23, 2022 and Feb 28, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “High Test Results” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K122584, K213426); 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.

Recalls naming this device

1. Apr 8, 2022Class IIOpen, Classified

   Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

   Z-1052-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 13, 2021Class IIOpen, Classified

   The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

   Z-0276-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2022High Test Results; High Test Results

  A COMPLAINT WAS RECEIVED INDICATING THAT A CUSTOMER REPORTED ERRONEOUS PATIENT CLOTTING TIME RESULTS (INR; INTERNATIONAL NORMALIZED RATIO) USING HEMOSIL READIPLASTIN, PART NUMBER 0020301400, LOT NUMBER N0806224, ON THE ACL TOP 550 CTS. PER THE CUSTOMER, ONE PATIENT WITH AN ERRONEOUSLY HIGH INR RESULT HAD THEIR TREATMENT ADJUSTED WITH THE ADMINISTRATION OF ORAL VITAMIN K. TO DATE, THERE IS NO REPORTED ADVERSE EVENT FROM THE CHANGE IN MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620718 ↗
• InjuryFeb 23, 2022High Test Results; High Test Results

  A COMPLAINT WAS RECEIVED INDICATING THAT A CUSTOMER REPORTED ERRONEOUS PATIENT CLOTTING TIME RESULTS (INR; INTERNATIONAL NORMALIZED RATIO) USING HEMOSIL READIPLASTIN, PART NUMBER 0020301400, LOT NUMBER N0806224, ON THE ACL TOP 500 CTS. THE INR RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY DESPITE THE LABORATORY'S QUALITY CONTROL RESULTS EXCEEDING THE MANUFACTURER'S QUALITY CONTROL PACKAGE INSERT RANGE. PER THE CUSTOMER, MULTIPLE PATIENTS WITH ERRONEOUSLY HIGH INR RESULTS HAD THEIR MANAGEMENT ALTERED (E.G., CHANGE IN TYPE OF ANESTHESIA, POSTPONEMENT OF SURGERY). TO DATE, THERE ARE NO REPORTED ADVERSE EVENTS FROM THESE CHANGES IN MANAGEMENT.

  Patient problems: Oversedation

  MAUDE report 13584277 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122584, K213426. One submission often covers many models, so check the product and lot details in each record.

• Z-0077-2019 · Aug 1, 2018 · Terminated
  Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissu
• Z-0895-2018 · Aug 2, 2017 · Terminated
  Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400