SEPPIM Recalls Calcium Arsenazo Reagent Due to Inaccurate Plasma Results
SEPPIM SAS is recalling Calcium Arsenazo reagent kits because plasma specimens may report higher calcium results than serum.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic inaccuracies without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
SEPPIM SAS is recalling Calcium Arsenazo, CALA-0250, a reagent used for the quantitative determination of total calcium in human serum. The recall was initiated due to complaints that plasma specimens report higher results than serum when using this reagent.
The affected product is intended for use on ELITech Clinical Systems Selectra Pro Series Analyzers and is not intended for Point of Care settings. The recall includes 47 kits distributed in the United States and 48 kits distributed in Sweden. In the US, the affected lots are 11-2614, 12-1002, and 12-2220. In Sweden, 15 specific lot numbers are affected.
Healthcare facilities and laboratories should stop using the affected reagent kits and contact SEPPIM SAS for instructions on return or replacement. This recall addresses potential inaccuracies in calcium measurements that could impact the diagnosis and treatment of conditions such as parathyroid disease, bone diseases, chronic renal disease, and tetany.
The recalled product
- 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…
- Manufacturer
- SEPPIM SAS
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
Distribution
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