GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test

FDA device recall Z-0348-2023 · posted 2022-11-30 · Terminated

Recall details

Recalling firm

Greer Laboratories, Inc.

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.

Action taken

The firm initiated the recall beginning on 10/25/2022 by telephone and email, following with a "MEDICAL DEVICE RECALL" notice. The notice stated the problem and requested the following: "Greer requests that you immediately discontinue use of the M. faeni Dia-Kit antigen lot(s) and return any remaining stock of the lots in question. Please contact a Greer Customer Service Representative at 1-800-378-3906 between 8 a.m. and 5 p.m. Eastern Time to receive a Returned Goods Authorization number and arrange for return of the product. Your Greer Customer Service Representative will also arrange for replacement of the product."

Root cause

Employee error

Status

Terminated

Product code

DGW

Quantity affected

102 units

Distribution

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

Date initiated

2022-10-25

Date posted

2022-11-30

Date terminated

2026-02-11

Location

Lenoir, NC