Recall Z-2301-2020 ยท GMJ Antigens, Histoplasma Capsulatum, All
Immuno-Mycologics, Inc
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
| Date | Nov 4, 2019 |
| Status | Terminated |
| Reason | False positive results due to potential contamination of reagent. |
| Root cause | Under Investigation by firm |
| Action | On November 04, 2019, the firm sent out an urgent medical device recall notification to customers via e-mail of voluntary recall of an antigen, due to false positive results. The antigen was distributed to customers between September 4, 2019 and October 14, 2019. 1 complaint associated with this issue was reported. There have been no reports of patient injury or death. Risk to Health: The firm reported that in the case of false-positives, clinicians who use immuno-diffusion (ID) results alone may unnecessarily treat patients. The results of any sample that ran negative using this lot of antige |
| Quantity | 155 vials |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 Immuno-Mycologics, Inc., May 5, 1983 |