---
title: "GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSE... — FDA record Z-0347-2023 | Is It on Recall"
description: "The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interp"
url: https://isitonrecall.com/recall/fda-device-z-0347-2023-greer-m-faeni-0-25-ml-20-mg-ml-item-k6-analyte-specific-reagent-hypersensitivity-pneumonitis-test-sy/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel d... — FDA record Z-0347-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Greer Laboratories, Inc.
- **Quantity**: 218 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0347-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0347-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Number 389591, exp 6/12/2023 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Dec 7, 2022
- **Recall initiation date**: Oct 25, 2022
- **Center classification date**: Nov 30, 2022
- **Termination date**: Feb 11, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0347-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Greer Laboratories, Inc. records](https://isitonrecall.com/brand/greer-laboratories-inc/)