Z-1020-2025Class II

HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

Name: Z-1020-2025 HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Creator: Instrumentation Laboratory
Published: 2024-12-18
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2024-12-18 / Open, Classified / root cause: labeling and UDI

FDA source

Instrumentation Laboratory began a recall of HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic on 2024-12-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1020-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-18
Posted: 2025-01-24
Recalling firm: Instrumentation Laboratory Co.
Product: HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Product code: KFF Assay, Heparin
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026)
Distribution: Worldwide - 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.
Product codes and lots: Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673; ****Lot numbers added 4/15/2026**** N0531891, N0733658, N0249207, N0442161, N0744673, N1147734, N020463, N0250464, N0452277, N0553155, N0754506;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1020-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1020-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-24

Product code KFF

K213464Class IIHemosIL Liquid Anti-XaInstrumentation Laboratory CO / cleared 2022-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)