Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Lot #750, Exp. 14 January 2004
Products Sold
Lot #750, Exp. 14 January 2004
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. due to Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
Recommended Action
Per FDA guidance
U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.
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, PR
Page updated: Jan 10, 2026