Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GREER M. FAENI Recalled by Greer Laboratories, Inc. Due to The product was recalled because stability evaluation of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Greer Laboratories, Inc. directly.
Affected Products
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Quantity: 218 units
Why Was This Recalled?
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
Where Was This Sold?
This product was distributed to 11 states: CA, CO, IA, KY, MD, MA, MO, NC, PA, UT, VA
About Greer Laboratories, Inc.
Greer Laboratories, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report