directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
USdirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Recalling Firm: Accriva Diagnostics, Inc.
Reason for Recall / Hazard
TranslatedAssayed Whole blood control contains labeling with incorrect performance range.
Product Description & Identification
TranslateddirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Affected Products
TranslateddirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 98979 |
| Address 1 | 6260 Sequence Dr |
| Code info | Lot #: A6DLA001 Unique Device Identifier: 10711234170373 |
| Postal code | 92121-4358 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 6060 |
| Reason for recall | Assayed Whole blood control contains labeling with incorrect performance range. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Center classification date | 20260616 |
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 directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2?
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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Overview
- Recalling FirmAccriva Diagnostics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hong Kong, Spain.
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🚨 SAFETY ALERT: Accriva Diagnostics, Inc. - directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 Check if your household is affected: https://therecallfile.com/recalls/directcheck-act-lr-whole-blood-quality-control-level-2-model-catalog-n/FDA-Z-2460-2026
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