Device recall: 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with C
FDA enforcement event 97961 is a device recall by an individual recalling firm (name withheld) of Brescia, initiated 29 Oct 2025 and classified Class II, with 2 product records.
FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Brescia, Italy. FDA names an individual as the recalling firm; this site does not publish people's names.
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0942-2026 | 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 | 122,850 units US | Class II | Ongoing | 24 Dec 2025 |
| Z-0943-2026 | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk | 122,850 units US | Class II | Ongoing | 24 Dec 2025 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.