Z-2323-2025Class II

HemosIL LMW Heparin Controls; Part Number: 0020300200

Name: Z-2323-2025 HemosIL LMW Heparin Controls; Part Number: 0020300200
Creator: Instrumentation Laboratory
Published: 2025-02-03
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2025-02-03 / Open, Classified / root cause: manufacturing process

FDA source

Instrumentation Laboratory began a recall of HemosIL LMW Heparin Controls; Part Number: 0020300200 on 2025-02-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2323-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-03
Posted: 2025-08-13
Recalling firm: Instrumentation Laboratory Co.
Product: HemosIL LMW Heparin Controls; Part Number: 0020300200;
Product code: KFF Assay, Heparin
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 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, Finland, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Macao, Malaysia, Mexico, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Vietnam.
Product codes and lots: Part Number: 0020300200; UDI-DI: 08426950472490; Lot Numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2323-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2323-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-13

Product code KFF

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)