Copan WASPLab Software Recall Over Results Overwrite Issue
Copan WASP is recalling WASPLab devices due to a software issue in the WebApp that may prevent users from overwriting results. The recall affects WebApp versions 2.33.1, 2.33.3, and 2.34.2.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. The software issue could affect the accuracy of microbiological test results, which may impact patient diagnosis and care. While no injuries or illnesses have been reported, the potential impact on medical device functionality warrants a Severe classification per the rubric.
Plain-English summary
Copan WASP is recalling WASPLab automated incubation and digital imaging devices due to a software issue in the WebApp user interface. The issue may prevent users from overwriting results, which could affect the accuracy or management of microbiological culture plate data.
The recall affects WASPLab devices with WebApp software versions 2.33.1, 2.33.3, and 2.34.2. The product is identified by model/catalog number W087 and is used for the incubation and digital imaging of agar culture plates streaked with human-derived microbiological specimens.
The devices were distributed nationwide in the state of Arizona. Copan WASP has identified one unit potentially affected by this issue.
Users should contact Copan WASP regarding the software issue. Healthcare facilities and laboratories using the affected WASPLab devices should follow their internal procedures for managing recalled medical devices and consult with Copan WASP for software updates or corrective actions.
The recalled product
- Product
- Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked w
- Manufacturer
- Copan WASP
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: WebApp version 2.33.1
- 2.33.3 and 2.34.2
Distribution
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