Reported Jun 8, 2016 · Terminated
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001).…
Medscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medscience Inc · 16469 Bridlewood Cir · Delray Beach, FL · 33445-6679
Is this the product you have?
- AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001)
- Contents8 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
- Lot codes and dates
- All lots
- Amount recalled
- 11,400 (Item 1000) & 380 (Item 1001)
Where it was sold
Why it was recalled
During an FDA inspection it was found that the products are marketed without a cleared 510k.
This product could cause temporary or reversible health problems — stop using it.
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