Z-0178-2014Class II

Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit...

Name: Z-0178-2014 Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit...
Creator: Seppim Sas
Published: 2013-09-04
License: https://open.fda.gov/license/

VitalScientific / initiated 2013-09-04 / Terminated / root cause: design

FDA source

SEPPIM SAS began a recall of 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... on 2013-09-04. FDA classified it as Class II and gives the reason as "Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0178-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-04
Posted: 2013-11-07
Terminated: 2013-12-12
Recalling firm: VitalScientific
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.
Product code: CJY Azo Dye, Calcium
Reason for recall: Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Root cause tag: design
FDA root cause: Device Design
Action: ELITech Group of Bothell, WA sent an Urgent: Product Recall Notice dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: " Laboratories must not use plasma for the determination of total calcium when using this product. The product can still be used to determine total calcium with serum sample. " ELITech Clinical Systems SAS has revised the package insert and kit box label for the CALCIUM ARSENAZO reagent reference CALA-0250. All mentions of the use of the plasma will be removed from the documentation. If you have inventory of CALCIUM ARSENAZO, reference CALA- 0250. All lots. in your laboratory, please discard the insert that you have and replace it with the insert enclosed with this notice. " If you have transferred any of this product to another location, please forward a copy this bulletin to that location. " All users receive CALCIUM ARSENAZO, CALA-0250, from distributors. To be certain everyone who is possibly affected by this change is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached receipt confirmation to Technical Support by fax (401-642-9003) within 48 hours of receipt. We apologize for the inconvenience that this situation can cause in your laboratories; we remain at your disposal for further information. If you have any questions, please contact Technical Support at 1-855-ELITECH (855-354-324) We thank you for your cooperation and the attention which you will give to this bulletin.
Quantity in commerce: 47 kits in US and 48 kits in Sweden
Distribution: Worldwide Distribution - US including the states of KY and UT and the country of Sweden.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0178-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0178-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-07

Product code CJY

K110830Class IIElitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; ElitechElitechgroup / cleared 2011-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)