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U.S. Department of Health and Human Services

Class 2 Device Recall 300uL Transfer Pipette

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 Class 2 Device Recall 300uL Transfer Pipettesee related information
Date Initiated by FirmJuly 14, 2023
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2620-2023
Recall Event ID 92832
Product Classification Micro pipette - Product Code JRC
ProductCOPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Code Information UDI-50841467100545 / Lot Codes: B104661 B202918 B203404 B203405 B204186 B204187 B204819 B204820 B300133 B300410 B300608 B300647 B300679 B301129 B301133 B301135 B301134
Recalling Firm/
Manufacturer		 Copan Diagnostics Inc
26055 Jefferson Ave
Murrieta CA 92562-6983
For Additional Information ContactFrancisco Cuerva
800-216-4016 Ext. 215
Manufacturer Reason
for Recall		Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce2,592 units
DistributionUS: CA OUS: None
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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