Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
FDA Recall Z-0919-03 · Posted 2003-06-05
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeCEK
Date Initiated2003-03-26
Date Terminated2004-11-16
Product Quantity29,273 (domestic); 4,967 (international)
Reason for Recall
Slides may exhibit random, elevated imprecision of results.
Firm Action
Notification via letter dated 3/26/03 with instructions to discard product.
Root Cause
Other
Distribution Pattern
Nationwide and Worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.