Z-2620-2023Class II

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

Name: Z-2620-2023 COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs
Creator: Copan Diagnostics Inc
Published: 2023-07-14
License: https://open.fda.gov/license/

COPAN Diagnostics, Inc. / initiated 2023-07-14 / Open, Classified / root cause: manufacturing process

FDA source

Copan Diagnostics Inc began a recall of COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs on 2023-07-14. FDA classified it as Class II and gives the reason as "Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2620-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-14
Posted: 2024-09-30
Recalling firm: COPAN Diagnostics, Inc.
Product: COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Product code: JRC Micro Pipette
Reason for recall: Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 2,592 units
Distribution: US: CA OUS: None
Product codes and lots: UDI-50841467100545 / Lot Codes: B104661 B202918 B203404 B203405 B204186 B204187 B204819 B204820 B300133 B300410 B300608 B300647 B300679 B301129 B301133 B301135 B301134

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2620-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2620-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20

Product code JRC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)