EXENT Analyser marked plates as passed without performing quality control
An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.
What this means for you
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: FDA Class II recall with a stated risk of false or missed M-protein detection, a risk of harm with no injuries reported in the source.
Plain-English summary
The EXENT Analyser, model/catalog number IE800.A, software version 1.0.20, is being recalled. The analyser is an automated instrument intended for qualitative and quantitative in vitro testing. The action covers one unit, serial number 101150, UDI 05051700020886.
It was reported that plates 2 and 3 were marked as passed although it appeared that quality control had not been performed on these plates, despite samples being measured. According to the manufacturer, the potential clinical hazards include false or missed detection of M-protein and falsely elevated or decreased M-protein concentration. The FDA classified the action as Class II.
Distribution was nationwide in the United States. The analyser is installed in a laboratory rather than sold to consumers.
The facility should identify the affected unit using the model number, serial number and UDI above and follow the instructions issued by the manufacturer, including any guidance on reviewing affected results.
The recalled product
- Product
- Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids
- Manufacturer
- The Binding Site Group, Ltd.
- 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 (9)
- Lot Code: Model No
- IE800A
- EXENT Analyser
- UDI
- 05051700020886
- Serial Number
- 101150
- Software version
- v1.0.20.
Distribution
Distributed nationwide across the United States.
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