Reported Nov 13, 2013 · Terminated
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows…
Seppim Sas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEPPIM SAS · ZONE INDUSTRIELLE · SEES, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot 11-2614, Expiration 07/2013. 2 Lot 12-1002; Expiration 03/2014. 3 Lot 12-2220, Expiration 08/2014. 4 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 - Amount recalled
- 47 kits in US and 48 kits in Sweden
Where it was sold
Why it was recalled
Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
This product could cause temporary or reversible health problems — stop using it.
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