Copan Transfer Pipette Recalled Due to Plastic Defects
Copan Diagnostics is recalling 2,592 units of 300µL transfer pipettes due to plastic defects that may affect aspiration capability. Affected units were distributed in California.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for plastic defects affecting device functionality. Although no illnesses or injuries have been reported, pipette defects in medical diagnostics represent a risk-of-harm product where accuracy directly impacts test results. Score 3 applies per rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Copan Diagnostics Inc is recalling a specific lot of 300µL transfer pipettes (Model REF: 2U045S01) distributed in the United States. The affected units are individually wrapped pipettes distributed in California, comprising 2,592 units total.
The pipettes are being recalled because plastic defects have been identified that may affect the aspiration capability of the device. The aspiration tolerance may not meet expected specifications.
The recall applies specifically to pipettes with lot codes B104661, B202918, B203404, B203405, B204186, B204187, B204819, B204820, B300133, B300410, B300608, B300647, B300679, B301129, B301133, B301135, and B301134.
Healthcare facilities and diagnostic laboratories that received pipettes from these lot codes should discontinue use and contact Copan Diagnostics Inc for instructions on returning the affected pipettes or obtaining replacement units.
The recalled product
- Product
- COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
- Manufacturer
- Copan Diagnostics Inc
- Affected units
- 2,592
Distribution
Distributed in 1 state:
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