Z-1843-2016Class II

AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item...

Name: Z-1843-2016 AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item...
Creator: Medscience Inc
Published: 2016-03-22
License: https://open.fda.gov/license/

Medscience Research Group, Inc. / initiated 2016-03-22 / Terminated

FDA source

Medscience Inc began a recall of 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... on 2016-03-22. FDA classified it as Class II and gives the reason as "During an FDA inspection it was found that the products are marketed without a cleared 510k". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1843-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-22
Posted: 2016-05-31
Terminated: 2017-10-13
Recalling firm: Medscience Research Group, Inc.
Product: 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
Product code: LDH
Reason for recall: During an FDA inspection it was found that the products are marketed without a cleared 510k.
FDA root cause: No Marketing Application
Action: MedScience sent an Urgent Recall letter dated March 28, 2016, to their customers to inform them of the product recall. The letter instructed customers to discontinue and refrain from further use of recalled products and to contact MedScience to arrange the return of products still in possession by the consignee. MedScience set up a phone line and email address for customers to ask questions and obtain further direction: (800) 393-8817 and [email protected].
Quantity in commerce: 11,400 (Item 1000) & 380 (Item 1001)
Distribution: Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1843-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1843-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code LDH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)