Recall Z-1020-2025

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: Under Investigation by firm

Action taken

On 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