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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74356

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

Open FDA event record

Event summary

Timeline bucket
May 24, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hardy Diagnostics

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

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.

Z-2146-2016
Recall number
Z-2146-2016
Initiated
May 24, 2016
Classification
Class II
Status
Terminated
Recalling firm
Hardy Diagnostics
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.

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

Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.

Code information

All units manufactured between October 2014 and May 2016.

Distribution pattern

U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.