HemosIL LMW Heparin Controls; Part Number: 0020300200;

FDA device recall Z-2323-2025 · posted 2025-08-13 · Open, Classified

Recall details

Recalling firm

Instrumentation Laboratory

Reason for recall

Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

Action taken

On February 3, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Requested Customer Actions Please take the following actions: " Follow the instructions in the original Urgent Medical Device Correction letter to update the ACL TOP test parameters with the corrected value assignments for HemosIL Heparin Calibrators (Part No. 0020300600). " For HemosIL UF Heparin Controls (Part No. 0020300300), continue to use the current target values and acceptance ranges as labeled. " For HemosIL LMW Heparin Controls (Part No. 0020300200), use the reassigned target values and acceptance ranges for the Low and High Controls as provided in the table above. " Note: if the 2D Barcode is scanned, customers need to manually override the uploaded values with those provided in this letter. " Follow the instructions below to update the Quality Control Material Definitions with the updated values (same instructions for all Instrument models): " Select Setup from the menu bar and then select Material List from the dropdown menu. " From Material List , double click on the Material Name LMW Hep Low Control and LMW Hep High Control (performed separately) to open Material Definition . " From Material Definition LMW Hep Low Control or LMW Hep High Control , click on Assigned Values icon (picture of bullseye) under the header. An editable table titled Assigned Values for IL Material Definition Quality Control LMW Hep Low Control or LMW Hep High Control will appear with the Anti-Xa Test Code, Active Lot, and Alternative Lot (if applicable). " In the Assigned Values table, select the Active and/or Alternative lot, and change the target values for LMW Hep Low Control and LMW Hep High Control to the reassigned values provided in the table. " After entering the reassigned values for LMW Hep Low Control and LMW Hep High Control , click on OK to save the changes. " Run quality controls per labeled instructions for use. New acceptance ranges for HemosIL L

Root cause

Process control

Status

Open, Classified

Product code

KFF

Quantity affected

41,824 units

Distribution

Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belarus, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark,

Date initiated

2025-02-03

Date posted

2025-08-13

Location

Bedford, MA

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