VITROS Chemistry Products GLU DT Slides GEN 56…

Date posted by the FDA

Nov. 4, 2006

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .

Reason

Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.

Distribution pattern

Worldwide Distribution

Quantity

93,252 boxes (25 slides per box) in total

Codes and lots

REF 153 2316

Recall started

Sept. 27, 2006

Device type

Glucose Oxidase, Glucose

Root cause (FDA)

Other

What the company told customers

On 9/26/06, the recalling firm notified its foreign affiliate consignees of this 'field correction', and instructed them to inform their customers who received these slides of this issue, provided them with an updated Calibration Data Module and instructed to re-calibrate these slides for continued use. On 9/27/06, all US end-use consignees were informed of this issue via Federal Express overnight letter (dated 9/27/06), and instructing them to re-calibrate these slides for continued use after they have installed the Calibration Data Module. The new CDMs were sent to all customers with VITROS DT 60/DT60 II Chemistry systems starting 9/27/06 concurrent with, but separate, from the correction letters. This includes consignees who purchased their GLU DT slides from distributors. On 9/28/06, all distributors were notified of this 'field correction', providing instructions and 'Questions & Answers' for them, and instructing them to inform their customers who received these slides of this issue. Calibration Data Modules were sent to all customers with VITROS DT 60/DT60 II Chemistry Systems.

Recall number

Z-0151-2007

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

Source: FDA · Medical device enforcement report, recall number Z-0151-2007. The agency record governs; check it and the company before acting.