Greer Laboratories, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0348-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 25, 2022

Date Posted: December 7, 2022

Recall Number: Z-0348-2023

Event ID: 91078

Reason for Recall:

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.

Status: Terminated

Product Quantity: 102 units

Code Information:

Lot Number 389592, exp 6/12/2023

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated