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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79631

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

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Event summary

Timeline bucket
March 14, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Accelerate Diagnostics 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

Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

Z-1529-2018
Recall number
Z-1529-2018
Initiated
March 14, 2018
Classification
Class II
Status
Terminated
Quantity
95 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

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

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

Code information

Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.

Distribution pattern

Distributed to IL, TX, CA, SC, and DE.