Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. ,
FDA device recall Z-1225-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 210,050 boxes
- Distribution
- Nationwide and worldwide distribution to distributors and end-users.
- Date initiated
- 2003-07-28
- Date posted
- 2003-09-11
- Date terminated
- 2003-11-24
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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