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.