Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 13, 2013
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 dis
Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Seppim Sas recalled Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human… - a moderate-severity action.
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human… was recalled by Seppim Sas in November 13, 2013. Reason: Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high r…. Check the official notice for the remedy. Verify recall #Z-0178-2014 with the FDA Devices before acting.
The recall
Seppim Sas issued this moderate-severity FDA Devices recall-Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high r….
- Moderate
- severity level
- Class II
- classification
- November 13, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0178-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0178-2014) was formally reported on November 13, 2013, with the manufacturer initiating the action on September 4, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Seppim Sas is listed as the recalling firm, operating out of SEES, N/A. Federal records list the affected scope as 47 kits in US and 48 kits in Sweden.
The documented reason for this recall is: Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including the states of KY and UT and the country of Sweden.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
47 kits in US and 48 kits in Sweden
Related Recalls
6
3 from same agency
Product description
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 for recall
Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0178-2014 |
| Date reported | November 13, 2013 |
| Date initiated | September 4, 2013 |
| Recalling firm | Seppim Sas |
| Firm location | SEES, N/A |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0178-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Seppim Sas. Units affected: 47 kits in US and 48 kits in Sweden.
Why was this product recalled? ▼
Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2013. Severity: Moderate. Recall number: Z-0178-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including the states of KY and UT and the country of Sweden..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0178-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 13, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.