PlainRecords1ml of DTT in liquid phase… and 1 more product
- Reason
- Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
- Status
- Ongoing
- Distribution
- US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
- Enforcement report date
- Dec. 24, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Copan Italia
- Distribution pattern
- US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.”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, FDA enforcement report, 2025-12-24. The caption is the record's own words.
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FDA device name: General Purpose Reagent
Distributed in (FDA's record): California Colorado Florida Georgia Minnesota Mississippi New Hampshire New Jersey New York Ohio Pennsylvania Tennessee Texas Utah
2 products in this recall
1ml of DTT in liquid phase…
- 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
- Reason
- Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
- Quantity
- 122,850 units US
- Codes and lots
- UDI:0U020N.A - (01)18053326005036
- Recall started
- Oct. 29, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- General Purpose Reagent
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On October 29, 2025, Copan initiated a Urgent: Medical Device Recall Notification via Email to affected consignees Copan ask consignees to take the following actions: 1. Further distribution or use of the remaining product must stop immediately: trace and dispose of all affected products. 2. This notice should be passed on to all those who need to be aware within your organization. 3. Ensure that the same obligations (communication to end users and related evaluation activities) are guaranteed by any additional Customer. In particular, if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter, in writing. If you have any questions, call Chief Operating Officer, at 030-2687211.
- Recall number
- Z-0942-2026
1ml of DTT in liquid phase…
- Product
- 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
- Reason
- Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
- Quantity
- 122,850 units US
- Codes and lots
- UDI:0U020N.A - (01)18053326005043
- Recall started
- Oct. 29, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- General Purpose Reagent
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On October 29, 2025, Copan initiated a Urgent: Medical Device Recall Notification via Email to affected consignees Copan ask consignees to take the following actions: 1. Further distribution or use of the remaining product must stop immediately: trace and dispose of all affected products. 2. This notice should be passed on to all those who need to be aware within your organization. 3. Ensure that the same obligations (communication to end users and related evaluation activities) are guaranteed by any additional Customer. In particular, if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter, in writing. If you have any questions, call Chief Operating Officer, at 030-2687211.
- Recall number
- Z-0943-2026
This recall among the others
- FDA's enforcement report came 56 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Copan Italia: 1 other recall or notice on this site in the three years before this one (from Dec. 25, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-0942-2026, Z-0943-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0942-2026, Dec. 24, 2025. "1ml of DTT in liquid phase… and 1 more product." PlainRecords, https://plainrecords.com/recall/device/z-0942-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections