Ortho-Clinical Diagnostics VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
01-5919, Exp. 5/31/2005 (EXPIRED): 01-6032, Exp. 9/30/2005 (EXPIRED), and 02-6284, Exp. 1/28/2006
Products Sold
01-5919, Exp. 5/31/2005 (EXPIRED): 01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006
Ortho-Clinical Diagnostics is recalling VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., due to Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
Recommended Action
Per FDA guidance
Letters dated 10/12/2005 issued to end users in the U.S. Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol. A return reply form is included. Foreign affiliates were notified via e-mail on 10/12/2005.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026