Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 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 CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Lot 611, Exp. 25 June 2004
Products Sold
Lot 611, Exp. 25 June 2004
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm 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
Customers notified via phone and faxed letter on 11/26/03. Customers provided with a modified QC procedure to be used until new shipments can be made.
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