Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73664

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

Open FDA event record

Event summary

Timeline bucket
March 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medscience 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

AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine

Z-1843-2016
Recall number
Z-1843-2016
Initiated
March 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medscience Inc
Quantity
11,400 (Item 1000) & 380 (Item 1001)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the products are marketed without a cleared 510k.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an FDA inspection it was found that the products are marketed without a cleared 510k.

Code information

All lots

Distribution pattern

Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.