Respiratory specimen reagent recalled because fluidification cannot be guaranteed
Copan Italia is recalling 122,850 units of 1ml DTT liquid reagent because treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
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: Scored 2 because the record states reagent functionality cannot be guaranteed without describing a consequence or any reported harm.
Plain-English summary
1ml of DTT in liquid phase, in a PET tube with capture cap, supplied in bulk, is being recalled by Copan Italia.
The reason given in the enforcement record is that treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
The record lists 122,850 units in the United States, carrying UDI 0U020N.A / (01)18053326005043. Distribution covered California, Colorado, Florida, Georgia, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Utah. The FDA has classified the action as Class II.
The record states that reagent functionality cannot be guaranteed and does not describe a further consequence or report injuries. Laboratories should follow Copan's instructions.
The recalled product
- Product
- 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
- Manufacturer
- Copan Italia
- Affected units
- 122,850
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)
- UDI:0U020N.A - (01)18053326005043
Distribution
Part of a larger recall action
This product is one of 2 recalled by Copan Italia 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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