Z-0347-2023Class II

GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test...

Name: Z-0347-2023 GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test...
Creator: Greer Laboratories, Inc.
Published: 2022-10-25
License: https://open.fda.gov/license/

Greer Laboratories Inc / initiated 2022-10-25 / Terminated / root cause: manufacturing process

FDA source

Greer Laboratories, Inc. began a recall of GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating... on 2022-10-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0347-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-25
Posted: 2022-11-30
Terminated: 2026-02-11
Recalling firm: Greer Laboratories Inc
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.
Product code: DGW System, Test, Hypersensitivity Pneumonitis
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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."
Quantity in commerce: 218 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
Product codes and lots: Lot Number 389591, exp 6/12/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0347-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0347-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-07	2022-11-30
Z-0348-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-07	2022-11-30

Product code DGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)