FDA Device recall Z-0848-2015
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0848-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-06 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Identifiers
| code_info | Lot 0704-3318-4774 (expiry date 01 Dec 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-0848-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.