# FDA recall Z-0347-2023

> **Greer Laboratories, Inc.** · Class II · device recall initiated 2022-10-25.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0347-2023
- **Recalling firm:** Greer Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-25
- **Report date:** 2022-12-07
- **Termination date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenoir, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2023

## Citation

> AI Analytics. FDA recall Z-0347-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0347-2023. Source: US FDA. Licensed CC0.

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