TEM Systems Recalls ex-TEM Assay Reagents Due to Low Vial Levels
TEM Systems Inc is recalling ex-TEM Assay reagents for the ROTEM delta system because customers reported low or empty vials.
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 issue involves low or empty vials which is a quality defect without reported injuries or illnesses, fitting the Moderate severity criteria for minor defects or precautionary recalls.
Plain-English summary
TEM Systems Inc is recalling 637 boxes of ex-TEM Assay for the ROTEM delta Thromboelastometry System. The affected product, Article No. 503-05 US, is used to monitor the coagulation process in citrated whole blood specimens. The recall involves Lot No. 21929007.
The recall was initiated after customers complained of low or empty reagent vials. The product was distributed nationwide to facilities in AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.
Healthcare facilities should stop using the affected lot and contact TEM Systems Inc for further instructions. This is a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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.
- 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 No. 21929007
Distribution
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