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Terminated

Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.]

FDA Recall Z-1225-03 · Posted 2003-09-11

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeCGA
Date Initiated2003-07-28
Date Terminated2003-11-24
Product Quantity210,050 boxes

Reason for Recall

Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator.

Firm Action

GLU Slides: Letters dated between 7/28/03 and 8/11/03 provide revised storage instructions. Customers using NaF/KOx blood collection tubes and have VITROS GLU slides that have been refrigerated for more than four months will receive replacement product. Those customers are instructed to continue to use the slides only until replacement product arrives. GLU DT Slides: Letters dated between 7/28/03 and 8/11/03 with the same instructions as for GLU slides.

Root Cause

Other

Distribution Pattern

Nationwide and worldwide distribution to distributors and end-users.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K841503KODAK EKTACHEM DT 60 ANALYZEREastman Kodak Company · 1984-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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