Recall Z-2620-2023 ยท JRC Micro Pipette
Copan Diagnostics Inc
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
| Date | Sep 30, 2024 (initiated Jul 14, 2023) |
| Status | Open, Classified |
| Reason | Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance |
| 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 an |
| Quantity | 2,592 units |
| Distribution | US: CA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.