Agency classClass IIOur severity:High FDA (Devices)·Z-0347-2023·Announced 2022-12-07

Medical laboratory reagent recalled for potential false-negative test results

Greer Laboratories recalled a hypersensitivity pneumonitis test reagent (Lot 389591) due to decreased reactivity that could cause false-negative results. The issue affects 218 units distributed across 12 U.S. states and two countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic test reagent with theoretical risk of false-negative results, which could delay diagnosis of hypersensitivity pneumonitis. However, no illnesses or injuries have been reported, and the hazard remains potential rather than confirmed in clinical use.

Plain-English summary

Greer Laboratories, Inc. recalled 218 units of GREER M. FAENI, a diagnostic gel diffusion kit used to detect precipitating antibodies in hypersensitivity pneumonitis testing. The affected lot (Number 389591, expiration 6/12/2023) was distributed to clinical and diagnostic laboratories in California, Colorado, Iowa, Kentucky, Massachusetts, Maryland, Missouri, North Carolina, Pennsylvania, Utah, Virginia, as well as to Canada and Denmark.

The product was recalled because stability testing revealed a decrease in reactivity that could lead to false-negative test results. The manufacturer discovered the issue during a 6-month stability evaluation in October 2021, which identified a failed potency test. A subsequent manufacturing investigation found that the initial potency test for the lot had been misinterpreted during the original lot release process, allowing defective material to be distributed.

If you use or have used this reagent lot for patient testing, contact Greer Laboratories immediately and review any test results generated with this material. Consider retesting any patients whose results may have been affected by a false-negative interpretation. Clinical laboratories should verify they do not possess this specific lot number and coordinate with their supplier on return or destruction procedures.

The recalled product

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.
Manufacturer: Greer Laboratories, Inc.
Category: Medical Device — Diagnostic Reagent
Hazard: false-negative-test-result
reagent-potency
Affected units: 218

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot Number 389591
exp 6/12/2023

Distribution

Distributed in 11 states:

Part of a larger recall action

This product is one of 2 recalled by Greer Laboratories, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Greer Laboratories, Inc.

See all →

High
Medical device test system recalled for decreased reactivity and false-negative results
FDA (Devices) · 2022-12-07

Same hazard · false negative test result