Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Lot 710, Exp. 7/28/05
Products Sold
Lot 710, Exp. 7/28/05
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on la due to Potential for positively biased results in QC and patient samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for positively biased results in QC and patient samples.
Recommended Action
Per FDA guidance
Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.
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