Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HemosIL Heparin Calibrators

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall HemosIL Heparin Calibratorssee related information
Date Initiated by FirmDecember 18, 2024
Date PostedJanuary 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1020-2025
Recall Event ID 96044
510(K)NumberK213464 
Product Classification Assay, heparin - Product Code KFF
ProductHemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Code Information Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673;
Recalling Firm/
Manufacturer		 Instrumentation Laboratory
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information ContactAnuja Khan
781-861-4451
Manufacturer Reason
for Recall		Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn December 18, 2024 URGENT MEDICAL DEVICE CORRECTION letters were email to customers. Mandatory Customer Actions Based on the above, please take the following immediate actions: - Check inventory for lots of HemosIL Heparin Calibrators (Part No. 0020300600). See Appendix A for a list of in-date lots with corrected value assignments for the HEP CAL 2 and HEP CAL 3 levels. - Follow the instructions below to update the ACL TOP test parameters (same instructions for all models): - Select Setup from the menu bar and then select Test List from the dropdown menu. - From Test List , double click on the Test Code Anti-Xa to open Test Definition Anti-Xa . - From Test Definition Anti-Xa, click on Pre-diluted calibrators under the header Calibration . An editable table titled Calibration points will appear with HEP CAL 1, HEP CAL 2, and HEP CAL 3 and their predefined Target Values IU/mL of 0.00, 0.80 and 2.00, respectively. - In the Calibration points table, change the target values for HEP CAL 2 and HEP CAL 3 to the lot-specific calibrator values provided in Appendix A. - After entering the corrected HEP CAL 2 and HEP CAL 3 values, click on the save icon (picture of floppy disk) to save the changes. - Recalibrate using the HemosIL Liquid Anti-Xa assay lot in use after making the test parameter update. - Run quality controls per labeled instructions for use. If needed, determine control ranges for HemosIL UF Heparin Controls (Part No. 0020300300) and HemosIL Low Molecular Weight Heparin Controls (Part No. 0020300200) in accordance with your internal protocol until the new acceptance ranges are available. - Repeat the above test parameter update, recalibration, and quality control for all ACL TOP instruments. - Share this information with your laboratory staff. - Forward this notification to all affected locations within your facility. - Retain a copy of this notification for your records. - Complete and sign the enclosed Mandatory Response Tracking Form a
Quantity in Commerce10,952 units (5,303 US, 5,649 OUS)
DistributionWorldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Korea (the Republic of), Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Mexico, Netherlands (the), Norway, Philippines (the), Poland, Portugal, Qatar, Romania, Russian Federation (the), Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan (Province of China), Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KFF
-
-