1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible wit
Summary
The FDA issued a Class II for 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum trans by Copan Italia. Reason: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed..
Details
Source
Device Recall
External ID
Z-0942-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI:0U020N.A - (01)18053326005036
Quantity Affected: 122,850 units US
Reason for Recall
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Distribution
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-29
Company
Brescia
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Copan Italia has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Copan Italia) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Copan Italia have FDA actions?
Copan Italia has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0942-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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