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U.S. Department of Health and Human Services

Class 2 Device Recall SL Solution 1ML in Bulk

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 Class 2 Device Recall SL Solution 1ML in Bulksee related information
Date Initiated by FirmOctober 29, 2025
Date PostedDecember 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0943-2026
Recall Event ID 97961
Product Classification General purpose reagent - Product Code PPM
Product1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Code Information UDI:0U020N.A - (01)18053326005043
Recalling Firm/
Manufacturer		 Copan Italia
Via Francesco Perotti 10, 18
Brescia Italy
For Additional Information ContactMs. elisabetta Zanella
030-2687211
Manufacturer Reason
for Recall		Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce122,850 units US
DistributionUS Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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