Heparin control material recalled after quality control results fell below acceptance range
HemosIL LMW Heparin Controls, part number 0020300200, are recalled after complaints of lower than expected quality control recovery. 41,824 units are affected.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The only consequence stated is delayed patient testing rather than erroneous patient results, which places this at rubric level 2 as a precautionary quality issue.
Plain-English summary
HemosIL LMW Heparin Controls, part number 0020300200, UDI-DI 08426950472490, are being recalled. The recall covers 41,824 units and lot numbers beginning N0330228, N0632773, N0935135 and continuing in the notice. Distribution was worldwide, including US nationwide and a long list of other countries.
The manufacturer received multiple complaints of lower than expected quality control results, and in some cases quality control 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 quality control resulted in patient testing delays. The FDA classified the action as Class II.
Laboratories using this control material should check the part number and lot numbers against the recall notice and follow the manufacturer's instructions for affected inventory.
The recalled product
- Product
- HemosIL LMW Heparin Controls; Part Number: 0020300200;
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 41,824
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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