Z-0151-2007

VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry...

Name: Z-0151-2007 VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry...
Creator: Ortho-Clinical Diagnostics
Published: 2006-09-27
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2006-09-27 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure... on 2006-09-27. The reason FDA records is "Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0151-2007
Status: Terminated
Initiated: 2006-09-27
Posted: 2006-11-04
Terminated: 2012-08-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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. .
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.
FDA root cause: Other
Action: 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.
Quantity in commerce: 93,252 boxes (25 slides per box) in total
Distribution: Worldwide Distribution
Product codes and lots: REF 153 2316

Product code CGA

K841503Class IKodak Ektachem Dt 60 AnalyzerEastman Kodak Company / cleared 1984-05-22

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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)