FDA Device recall Z-3043-2018
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only
- FDA Device
- Class III
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class III recall of VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing the slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was obser….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3043-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-07-11 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason
The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
Identifiers
| code_info | GEN 5 and below |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3043-2018%22
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