Recall Z-1843-2016— Medscience Inc
Class II · Terminated
Class II FDA medical device recall by Medscience Inc, initiated 2016-03-22, terminated 2017-10-13. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: During an FDA inspection it was found that the products are marketed without a cleared 510k..
- Recalling firm
- Medscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-22
- Terminated
- 2017-10-13
- Firm location
- Delray Beach, FL, United States
Product description
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
Reason for recall
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Data sourced from openFDA. This site is unofficial and independent of the FDA.