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

This recall is currently active, issued September 30, 2024. It was issued by Copan Diagnostics Inc.

Company: Copan Diagnostics Inc
Recall Initiated: July 14, 2023
Posted: September 30, 2024
Recall Number: Z-2620-2023
Quantity: 2,592 units
Firm Location: Murrieta, CA
Official Source: View on FDA website ↗

Reason for Recall

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

Distribution

US: CA OUS: None

Lot / Code Info

UDI-50841467100545 / Lot Codes: B104661 B202918 B203404 B203405 B204186 B204187 B204819 B204820 B300133 B300410 B300608 B300647 B300679 B301129 B301133 B301135 B301134

Root Cause

Process control

Action Taken

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 Francisco.Cuerva@copangroup.com 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