The Recall Desk
ModerateFDA (Devices)·Z-0942-2026·Announced 2025-12-24

Sputum transfer reagent sets recalled because liquification cannot be guaranteed

Copan Italia is recalling 122,850 units of 1ml DTT reagent supplied with a sputum transfer device because treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

What this means for you

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 with a sputum transfer device for use with Copan's WASP (Walk-Away Specimen Processor for Microbiology) System, is being recalled by Copan Italia.

The reason given in the enforcement record is that treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

The record lists 122,850 units in the United States, carrying UDI 0U020N.A / (01)18053326005036. 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 + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
Manufacturer
Copan Italia
Category
Medical Device — Laboratory reagent
Hazard
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)18053326005036

Distribution

Distributed in 14 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Copan Italia

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