---
title: "Alinity m HBV AMP Kit (US and CE) — FDA record Z-0884-2022 | Is It on Recall"
description: "There is a potential for misquantitation high results for negative samples."
url: https://isitonrecall.com/recall/fda-device-z-0884-2022-alinity-m-hbv-amp-kit-us-and-ce/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Alinity m HBV AMP Kit (US and CE) — FDA record Z-0884-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Alinity m HBV AMP Kit (US and CE)
- **Reason**: There is a potential for misquantitation high results for negative samples.
- **Classification**: Class II
- **Recalling firm**: Abbott Molecular, Inc.
- **Quantity**: 4966 kits, updated 101/17/2023
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0884-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0884-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Apr 13, 2022
- **Recall initiation date**: Mar 4, 2022
- **Center classification date**: Apr 6, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0884-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abbott Molecular, Inc. records](https://isitonrecall.com/brand/abbott-molecular-inc/)