LMW Heparin Controls not meeting quality acceptance specifications
Instrumentation Laboratory is recalling HemosIL LMW Heparin Controls due to lower than expected quality control results. Some units fall below acceptance specifications, delaying laboratory patient testing procedures.
What this means for you
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: This is a Class II medical device recall where quality control materials are failing to meet acceptance specifications with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported merit a High rating.
Plain-English summary
Instrumentation Laboratory is recalling 41,824 units of HemosIL LMW Heparin Controls (Part Number 0020300200), which are laboratory materials used to verify the accuracy of blood coagulation testing equipment.
Multiple complaints indicate that some units show lower than expected quality control results. In some cases, the quality control recovery fell below the lower limit of the acceptance range specified in the product package insert when tested with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. These failures prevented laboratories from passing their quality control validation procedures.
When these control materials fail to meet specifications, laboratories cannot complete their quality control validation and must delay patient testing. If your laboratory has received these products (affected lot numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397), do not use them for quality control procedures. Contact Instrumentation Laboratory for replacement or guidance. The affected products were distributed worldwide including the US.
The recalled product
- Product
- HemosIL LMW Heparin Controls; Part Number: 0020300200;
- Manufacturer
- Instrumentation Laboratory
- Hazard
- quality-control-failure
- testing-delay
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 (11)
- Part Number: 0020300200
- UDI-DI: 08426950472490
- Lot Numbers: N0330228
- N0632773
- N0935135
- N1036592
- N0148986
- N0441476
- N0643673
- N0845161
- N1147397
Distribution
Distributed nationwide across the United States.
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