Z-0919-03

Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum...

Name: Z-0919-03 Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum...
Creator: Ortho-Clinical Diagnostics
Published: 2003-03-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2003-03-26 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of 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... on 2003-03-26. The reason FDA records is "Slides may exhibit random, elevated imprecision of results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0919-03
Status: Terminated
Initiated: 2003-03-26
Posted: 2003-06-05
Terminated: 2004-11-16
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: 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.
Product code: CEK Biuret (Colorimetric), Total Protein
Reason for recall: Slides may exhibit random, elevated imprecision of results.
FDA root cause: Other
Action: Notification via letter dated 3/26/03 with instructions to discard product.
Quantity in commerce: 29,273 (domestic); 4,967 (international)
Distribution: Nationwide and Worldwide.
Product codes and lots: All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.

Product code CEK

K812028Class IIKodak Ektachem Clin. Chem. Slides (Tp)Eastman Kodak Company / cleared 1981-08-03

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)