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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91001

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 12, 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

1 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 1

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

Z-0268-2023
Recall number
Z-0268-2023
Initiated
October 12, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Abbott Molecular, Inc.
Quantity
883 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software would error

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

Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.

Code information

All serial numbers

Distribution pattern

Worldwide distribution.