Instrumentation Laboratory Recalls HemosIL Plasminogen IVD Kits
Instrumentation Laboratory is recalling specific lots of HemosIL Plasminogen kits because they do not meet labeled stability claims.
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 recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Instrumentation Laboratory Co. is recalling specific lots of the HemosIL Plasminogen in vitro diagnostic (IVD) kit. The affected product is identified by Part No. 0020009000, Lot No. N0455811, and an expiration date of 03/31/2017. The kit contains 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate.
The recall was initiated because the affected lot is not meeting the labeled on-board instrument stability claims of 5 days. This deviation from the labeled specifications may affect the reliability of the test results.
A total of 108 kits were distributed domestically in the United States, and 197 kits were distributed to foreign countries including Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela. Users of this product should contact Instrumentation Laboratory Co. for further instructions.
The recalled product
- Product
- HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
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 (2)
- Lot No. N0455811
- Expiration Date 03/31/2017
Distribution
Distribution scope not specified by the agency.
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