Ortho-Clinical Diagnostics VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
01-5871, Exp. 31Jan06
Products Sold
01-5871, Exp. 31Jan06
Ortho-Clinical Diagnostics is recalling VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent f due to Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
Recommended Action
Per FDA guidance
Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.
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