PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 7, 2022 Initiated: October 25, 2022 #Z-0347-2023

Product Description

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.

Details

Recalling Firm
Greer Laboratories, Inc.
Units Affected
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
Location
Lenoir, NC

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Greer Laboratories, Inc.. Units affected: 218 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2022. Severity: Moderate. Recall number: Z-0347-2023.

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