Z-0347-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- October 25, 2022
- Termination Date
- February 11, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218 units
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.
Distribution Pattern
US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark
Code Information
Lot Number 389591, exp 6/12/2023