Nichols Institute Diagnostics Nichols Advantage ACTH Test System, catalog number 62-7004. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nichols Advantage ACTH Test System, catalog number 62-7004.
Brand
Nichols Institute Diagnostics
Lot Codes / Batch Numbers
Lot 62-500040 and 62-404296
Products Sold
Lot 62-500040 and 62-404296
Nichols Institute Diagnostics is recalling Nichols Advantage ACTH Test System, catalog number 62-7004. due to Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
Recommended Action
Per FDA guidance
Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026