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U.S. Department of Health and Human Services

Class 2 Device Recall GREER

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  Class 2 Device Recall GREER see related information
Date Initiated by Firm October 25, 2022
Date Posted November 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-0348-2023
Recall Event ID 91078
Product Classification System, test, hypersensitivity pneumonitis - Product Code DGW
Product GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Code Information Lot Number 389592, exp 6/12/2023
Recalling Firm/
Manufacturer		 Greer Laboratories, Inc.
639 Nuway Cir
Lenoir NC 28645-3646
For Additional Information Contact
828-754-5327
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Action The firm initiated the recall beginning on 10/25/2022 by telephone and email, following with a "MEDICAL DEVICE RECALL" notice. The notice stated the problem and requested the following: "Greer requests that you immediately discontinue use of the M. faeni Dia-Kit antigen lot(s) and return any remaining stock of the lots in question. Please contact a Greer Customer Service Representative at 1-800-378-3906 between 8 a.m. and 5 p.m. Eastern Time to receive a Returned Goods Authorization number and arrange for return of the product. Your Greer Customer Service Representative will also arrange for replacement of the product."
Quantity in Commerce 102 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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