—#29040

Product

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 product code: CGA — Glucose Oxidase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K955286
Affected lot / code info: All lots with an expiration date of 1 December 2004 and earlier.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14650-0881

Distribution

Distribution pattern: Nationwide and worldwide distribution to distributors and end-users.

Timeline

Recall initiated: 2003-07-28
Posted by FDA: 2003-09-11
Terminated: 2003-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29040. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.