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
- Hazard
- reagent-functionality
- specimen-processing
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:
- CA
- CO
- FL
- GA
- MN
- MS
- NH
- NJ
- NY
- OH
- PA
- TN
- TX
- UT
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