ELITech Clinical Systems reagents recalled for potential drug interference
ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.
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 source explicitly states that no complaints were received, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ELITech Clinical Systems SAS is recalling specific reagents used on the Selectra ProS and ProM systems. The affected products utilize the Trinder Reaction method and include reference numbers GPSL-025O, AUML-0250, CHSL-0250, TGML-0250, CRSL-0250, HDLL-0230, and LDLL-0230. The recall covers 969 systems distributed nationwide in the United States.
The recall is being conducted due to potential drug interference. The source text states that no complaints were received regarding this issue.
Users of these reagents should contact ELITech Clinical Systems SAS for further instructions on how to proceed with the recall.
The recalled product
- Product
- ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250…
- Manufacturer
- ELITech Clinical Systems SAS
- Hazard
- Affected units
- 969
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)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by ELITech Clinical Systems SAS 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.
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