Exact FDA event identifier

Event 89757

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 04, 2022
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Abbott Molecular, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Alinity m HBV Application Specification File (US and CE)

Z-0883-2022

Recall number: Z-0883-2022
Initiated: March 04, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Abbott Molecular, Inc.
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential for misquantitation high results of negative samples.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for misquantitation high results of negative samples.

Code information

List Numbers: 1) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00

Distribution pattern

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

device · product 2 of 2

Alinity m HBV AMP Kit (US and CE)

Z-0884-2022

Recall number: Z-0884-2022
Initiated: March 04, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Abbott Molecular, Inc.
Quantity: 4966 kits, updated 101/17/2023