Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
USAtellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Recalling Firm: Siemens Healthcare Diagnostics, Inc.
Motivo del Retiro / Peligro
TranslatedProcessing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
Descripción del Producto e Identificación
TranslatedAtellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Additional Source Details
| Field | Value |
|---|---|
| City | Tarrytown |
| State | NY |
| Event id | 99389 |
| Address 1 | 511 Benedict Ave |
| Code info | All Lots within expiry/UDI: 00630414611099 |
| Postal code | 10591-5005 |
| Report date | 20260812 |
| Product type | Devices |
| Product quantity | 7018 units |
| Reason for recall | Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260706 |
| Center classification date | 20260805 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableSiemens Healthcare Diagnostics, Inc.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿
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🚨 SAFETY ALERT: Siemens Healthcare Diagnostics, Inc. - Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic Check if your household is affected: https://therecallfile.com/es/recalls/atellica-ch-urine-albumin-ref-11537225-in-vitro-diagnostic/FDA-Z-2890-2026
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