Instrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
Instrumentation Laboratory Co. is recalling 44 ROTEM ex-tem kits (Lot 42255801) because they may produce prolonged clotting times.
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 (prolonged clotting times) that poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Instrumentation Laboratory Co. is recalling 44 units of the ROTEM ex-tem Canada Part No: 503-05-CA. The recall is being conducted because the affected kits may result in prolonged clotting times.
The affected product is identified by Lot # 42255801. The recall covers distribution in the United States (Illinois, Wisconsin, Michigan) and numerous international locations including Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, 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 kits and contact Instrumentation Laboratory Co. for further instructions or a replacement.
The recalled product
- Product
- ROTEM ex-tem Canada Part No: 503-05-CA
- Manufacturer
- Instrumentation Laboratory Co.
- Hazard
- Affected units
- 44
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 # : 42255801 (Canada)
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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