Nichols Institute Diagnostics Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
Brand
Nichols Institute Diagnostics
Lot Codes / Batch Numbers
Lots 62-402598 and 62-402622
Products Sold
Lots 62-402598 and 62-402622
Nichols Institute Diagnostics is recalling Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040 due to Values do not agree with Directional Instructions.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Values do not agree with Directional Instructions.
Recommended Action
Per FDA guidance
Firm sent separate notices for each lot of product to customers dated March 25, 2005 requesting destruction of remaining product and affirmation of that activity via a response form. Users were also provided detailed listing of performance characteristics related to the deficiencies for thier information and evaluation per thier own lab''s SOP''s.
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