Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
USSyva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Recalling Firm: Siemens Healthcare Diagnostics, Inc.
Motif du rappel / Danger
TranslatedOut-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
Description du produit & Identification
TranslatedSyva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Produits concernés
TranslatedSyva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Additional Source Details
| Field | Value |
|---|---|
| City | Newark |
| State | DE |
| Event id | 99379 |
| Address 1 | 500 Gbc Dr |
| Code info | UDI-DI 00842768001406 Lot U1 |
| Postal code | 19702-2466 |
| Report date | 20260812 |
| Product type | Devices |
| Product quantity | 8 US; 44 OUS |
| Reason for recall | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260626 |
| Initial firm notification | Letter |
| Center classification date | 20260804 |
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 Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL?
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.
Vérifiez les autres produits de votre foyer
Outils gratuitsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Aperçu
- Entreprise responsableSiemens Healthcare Diagnostics, Inc.
- StatusOngoing
- Niveau de risqueClass III
- DistributionWorldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
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🚨 SAFETY ALERT: Siemens Healthcare Diagnostics, Inc. - Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL Check if your household is affected: https://therecallfile.com/fr/recalls/syva-emit-disopyramide-assay-enzyme-immunoassay-lidocaine-smn-10445370/FDA-Z-2880-2026
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