—#30719

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.

FDA product code: JHX — Fluorometric Method, Cpk Or Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K993068
Affected lot / code info: Lot 611, Exp. 25 June 2004

Why it was recalled

Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14650-0881

Distribution

Distribution pattern: 738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.

Timeline

Recall initiated: 2003-11-26
Posted by FDA: 2004-01-06
Terminated: 2004-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30719. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.