Greer Laboratories, Inc.: 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 investigatio

Agency Publication Date: November 30, 2022

Affected Products

Product: 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.

Lot Number 389591, exp 6/12/2023

Lot Numbers:

Number

Product: GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

Lot Number 389592, exp 6/12/2023

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91078

Status: Resolved

Manufacturer: Greer Laboratories, Inc.

Manufactured In: United States

Units Affected: 2 products (218 units; 102 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: 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.

Lot Number 389591, exp 6/12/2023

Lot Numbers:

Number

Product: GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

Lot Number 389592, exp 6/12/2023

Lot Numbers:

Number