Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74140

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

Open FDA event record

Event summary

Timeline bucket
February 19, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integrated Science Systems 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

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

Z-1911-2016
Recall number
Z-1911-2016
Initiated
February 19, 2016
Classification
Class II
Status
Terminated
Quantity
2625 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

Code information

Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043

Distribution pattern

Nationwide distribution to CA only.