FDA Device recall Z-0307-2014
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382 by Ortho Clinical Diagnostics, citing ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively me….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0307-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-12 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
Reason
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Identifiers
| code_info | Multiple lots affected, with expiry dates through 22-Mar-2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0307-2014%22
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