TEM Systems Recalls ROTROL P Control for Thromboelastometry System
TEM Systems Inc is recalling ROTROL P Control quality control material due to customer complaints about failed target ranges for alpha angle.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to quality control performance issues (failed target ranges) rather than direct patient harm, fitting the criteria for a moderate severity score.
Plain-English summary
TEM Systems Inc is recalling 476 boxes of ROTROL P Control for the ROTEM delta Thromboelastometry System. This product is a quality control material used for in vitro diagnostic purposes to monitor the accuracy and precision of tests carried out on the system. The recall involves Lot 41925401.
The recall was initiated due to customer complaints regarding failed target ranges for the alpha angle. The firm has not yet completed the corrective and preventive action (CAPA) process to identify the root cause of the issue, with projected completion in July 2016.
The affected product was distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV, and in Germany. Users should stop using the affected product and contact TEM Systems Inc for further instructions.
The recalled product
- Product
- ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
- Manufacturer
- TEM Systems Inc
- 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 (1)
- Lot 41925401
Distribution
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