Copan Transfer Pipette (Copan) – Aspiration Defect (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Brand
Copan Diagnostics Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-50841467100545 / Lot Codes: B104661 B202918 B203404 B203405 B204186 B204187 B204819 B204820 B300133 B300410 B300608 B300647 B300679 B301129 B301133 B301135 B301134
Copan Diagnostics Inc is recalling COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs. due to Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026