Vitros Immunodiagnostic Products CEA REAGENT PACK…

Date posted by the FDA

Jan. 6, 2004

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

Reason

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

Distribution pattern

154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.

Quantity

524 reagent packs

Codes and lots

Lot #750, Exp. 14 January 2004

Recall started

Dec. 3, 2003

Device type

System, Test, Carcinoembryonic Antigen

Root cause (FDA)

Other

What the company told customers

U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.

Recall number

Z-0299-04

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0299-04. The agency record governs; check it and the company before acting.