Abbott Alinity m HCV Kit Recalled for False Positive Results
Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.
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: This is a Class II diagnostic device recall with no reported illnesses, injuries, or hospitalizations. However, false positive HCV test results pose a risk of patient harm through unnecessary medical treatment and psychological distress from incorrect diagnosis, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Alinity m HCV AMP Kit is a reverse transcription-polymerase chain reaction (RT-PCR) diagnostic assay manufactured by Abbott Molecular, Inc. It is used with the automated Alinity m System to detect and measure hepatitis C virus (HCV) RNA in human serum or plasma. The recall affects 1,881 units distributed worldwide, with specific lot numbers identified: 381582, 382448, 383204, 383203, 385720, 381581, and 382447.
Abbott has received reports of an increase in false positive results and reactive negative controls when using the affected lots. False positive results occur when patient samples test positive for HCV when the virus is not actually present. Reactive negative controls are control samples that should not show reactivity but are doing so with these lots, indicating a quality control or manufacturing defect.
The recall affects healthcare facilities and laboratories worldwide that use the Alinity m System with the identified lot numbers of the HCV AMP Kit.
The recalled product
- Product
- Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in hum
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 1,881
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)
- a) 08N50-095: UDI/DI 00884999047648
- Lot Numbers: 381582
- 382448
- 383204
- b) 08N50-090: UDI/DI 00884999047761
- Lot Numbers: 383203
- 385720
- 381581
- 382447
Distribution
Distribution scope not specified by the agency.
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