IMMUNOSTICS, INC.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Antigens, All Groups, Streptococcus Spp.Product code GTY (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3740
Recalls & enforcement
- Class IIOngoing2023-08-25Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
FDA inspections (1)
- VAI2017-11-08Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “IMMUNOSTICS, INC. (FEI 2244821) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2244821-immunostics-inc/
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