FDA Device recall Z-0178-2014
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum by Seppim Sas, citing calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0178-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-04 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Seppim Sas |
| Distribution | KY, UT |
Product
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
Reason
Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Identifiers
| code_info | Lot numbers distributed in the US: Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220,…Lot numbers distributed in the US: Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014. Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408 |
|---|
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-0178-2014%22
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