Instrumentation Laboratory Recalls 722 ROTEM ex-tem Kits Due to Prolonged Clotting Times
Instrumentation Laboratory is recalling 722 ROTEM ex-tem kits because they may produce prolonged clotting times. The recall affects units distributed in the US and internationally.
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: The recall is classified as FDA Class II and involves a medical device defect that could lead to inaccurate diagnostic results (prolonged clotting times), posing a risk of harm without reported injuries.
Plain-English summary
Instrumentation Laboratory Co. is recalling 722 units of the ROTEM ex-tem (Rest of the world part No: 503-05) due to a defect that may cause prolonged clotting times. The affected product is identified by Lot # 42255701.
The recall covers units distributed in the United States (Illinois, Wisconsin, Michigan) and in numerous international locations, including Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, the United Kingdom, Germany, the Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, and Serbia.
Healthcare providers and consumers should stop using the affected ROTEM ex-tem kits and contact Instrumentation Laboratory Co. for instructions on return or replacement.
The recalled product
- Product
- ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 722
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 (1)
- Lot # : 42255701
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Instrumentation Laboratory Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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