COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Summary
The FDA issued a Class II for COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 p by Copan Diagnostics Inc. Reason: Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance.
Details
Source
Device Recall
External ID
Z-2620-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Lot/Code Info: UDI-50841467100545 / Lot Codes: B104661 B202918 B203404 B203405 B204186 B204187 B204819 B204820 B300133 B300410 B300608 B300647 B300679 B301129 B301133 B301135 B301134
Quantity Affected: 2,592 units
Reason for Recall
Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance
Distribution
US: CA OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-14
Company
Murrieta, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Copan Diagnostics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Copan Diagnostics Inc have FDA actions?
This is the only FDA action we have on record for Copan Diagnostics Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2620-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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