Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]
FDA Recall Z-1224-03 · Posted 2003-09-11
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeCGA
Date Initiated2003-07-28
Date Terminated2003-11-24
Product Quantity487,912 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. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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