FDA-Device2022-12-07Class II

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.

Greer Laboratories, Inc.

Hazard

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.

Sold states

US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark

Affected count

218 units

Manufactured in

639 Nuway Cir, Lenoir, NC, United States

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2023

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