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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90789

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

Open FDA event record

Event summary

Timeline bucket
August 19, 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

Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.

Z-1679-2022
Recall number
Z-1679-2022
Initiated
August 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Abbott Molecular, Inc.
Quantity
579 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports received of an increase of message code 9186 (internal control failed) when using the kit.

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

Reports received of an increase of message code 9186 (internal control failed) when using the kit.

Code information

Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.

Distribution pattern

Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.