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Recall Observatory FDA recall evidence

Device product

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

Z-2620-2023

July 14, 2023

Class II

Product summary

Firm
Copan Diagnostics Inc
Event
Event 92832
Status
Ongoing
Classification
Class II
Quantity
2,592 units
Official record key
device-enforcement:Z-2620-2023

Official wording

Reason: Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance

Code information: UDI-50841467100545 / Lot Codes: B104661 B202918 B203404 B203405 B204186 B204187 B204819 B204820 B300133 B300410 B300608 B300647 B300679 B301129 B301133 B301135 B301134

Distribution pattern: US: CA OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance