Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US Recalled by TEM Systems Inc Due to Customers complained of low/empty reagent vials.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TEM Systems Inc directly.
Affected Products
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
Quantity: 637 boxes x 10 vials
Why Was This Recalled?
Customers complained of low/empty reagent vials.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About TEM Systems Inc
TEM Systems Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report