COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance

On 7/14/2023, Copan issued an "Urgent: Medical device Recall" notification. A revised notification was sent on August 17, 2023. Copan asked consignees to take the following actions: 1. This notice should be passed on to all those who need to be aware within your organization. 2. Identify, segregate, and discontinue use of all affected products included in the table below 3. Identify and evaluate, based on the communicated issue, any sub-recall activities as applicable. 4. Ensure that the same obligations (communication to end users and related evaluation activities) are guaranteed by any additional Economic Operators (e.g., Distributor), if any. 5. Confirm you have read and understood the recall instructions provided in the letter, in writing using ATTACHMENT #1. 6. Dispose of or request for the return and the substitution of each 300L TRANSFER PIPETTE. 7. Disposal must be performed according to local regulation, and it does not require biohazard disposal precautions. Evidence or declaration of Product disposal must be returned in writing, using ATTACHMENT #2, by email, to: Francisco Cuerva Copan Diagnostics, Inc. 2728 Loker Avenue West. Carlsbad, CA 92010 Phone: 800.216.4016 x215 Mob. 951.219.6622 | Fax.951.600.1832 [email protected] 8. If you are not in the position to identify, segregate or discard the Product you must advise in writing using ATTACHMENT #1, by email, to: Francisco Cuerva