Z-0298-04

Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the...

Name: Z-0298-04 Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the...
Creator: Ortho-Clinical Diagnostics
Published: 2003-11-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2003-11-26 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK on 2003-11-26. The reason FDA records is "Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0298-04
Status: Terminated
Initiated: 2003-11-26
Posted: 2004-01-06
Terminated: 2004-02-20
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JHX Fluorometric Method, Cpk Or Isoenzymes
Reason for recall: Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 774 reagent packs
Distribution: 738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.
Product codes and lots: Lot 611, Exp. 25 June 2004

Product code JHX

K993068Class IIVitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products Ck-Mb CalibratorsOrtho-Clinical Diagnostics / cleared 1999-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)