HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device with quality control failures affecting diagnostic accuracy of heparin testing. No illnesses or injuries have been reported, but the defective controls pose a risk of missed equipment malfunctions in high-risk anticoagulation monitoring.
Plain-English summary
HemosIL Heparin Calibrators (Part Number 0020300600) are quality control materials used in clinical laboratories to verify the accuracy of heparin testing equipment. These in vitro diagnostic controls are manufactured by Instrumentation Laboratory.
The recall addresses quality control failures identified in the recalled lot numbers. Testing revealed that the controls produced lower-than-expected results, and in some instances, quality control recovery was below the acceptable limits specified in the product's package insert. When quality controls malfunction, laboratories may not detect problems with their heparin testing systems, potentially resulting in inaccurate patient test results.
The recalled calibrators were distributed worldwide, including approximately 5,303 units to clinical laboratories in the United States and approximately 5,649 units to other countries across more than 40 nations. Additional units were identified and added to the recall in April 2026. The recall covers specific lot numbers identified by Instrumentation Laboratory.
The recalled product
- Product
- HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
- Manufacturer
- Instrumentation Laboratory
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- N1147734
- N020463
- N0250464
- N0452277
- N0553155
- N0754506
Distribution
Distributed nationwide across the United States.
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