FDAClass II · Medical device · Recall Z-2460-2026 · Recalled June 24, 2026

directCHECK ACT-LR whole blood quality control recall — Accriva Diagnostics, Inc.

Agency report date: June 24, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: directCHECK ACT-LR whole blood quality control
Company / brand: Accriva Diagnostics
Lot / serial / date codes: Lot #: A6DLA001 Unique Device Identifier: 10711234170373
Distribution: Worldwide - 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.

Agency product description and boundaries

directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Assayed Whole blood control contains labeling with incorrect performance range.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: directCHECK ACT-LR whole blood quality control recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2460-2026
Brand: All Accriva Diagnostics recalls
Classification: Class II
Units affected: 6,060
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

directCHECK ACT-LR whole blood quality control recall status

Companies & origin

Recalling firm location: San Diego, CA, United States
Firm address: 6260 Sequence Dr, 92121-4358

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: A6DLA001 Unique Device Identifier: 10711234170373
Distribution: Worldwide - 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.
FDA event ID: 98979
Recall initiated: April 30, 2026
FDA classified: June 16, 2026
FDA report date: June 24, 2026

Other medical device recalls from around the same time

Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Impella CP Set with SmartAssist recall — Abiomed, Inc.FDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 22, 2026 at 6:00 PM UTC.

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