Recall Z-0348-2023 ยท DGW System, Test, Hypersensitivity Pneumonitis
Greer Laboratories, Inc.
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.
| Date | Nov 30, 2022 (initiated Oct 25, 2022) |
| Status | Terminated |
| Reason | 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 l |
| Root cause | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.