CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report

directCHECK Act-lr whole blood quality control, level recalled

Accriva Diagnostics is recalling directCHECK Act-lr whole blood quality control, level 2, distributed nationwide in the US. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: A6DLA001 Unique Device Identifier: 10711234170373

Quantity recalled6060

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2460-2026
FDA event ID: 98979
Recalling firm: Accriva Diagnostics, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 30 Apr 2026
FDA classified: 16 Jun 2026
Reported: 24 Jun 2026
Type: Voluntary: Firm initiated
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

30 Apr 2026	Recall initiated by company
16 Jun 2026	Classified by FDA	+47 days
24 Jun 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Assayed Whole blood control contains labeling with incorrect performance range.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Florida Georgia Idaho Illinois Indiana Kentucky Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina New Jersey New Mexico New York

Questions about this recall

Why was it recalled?

Assayed Whole blood control contains labeling with incorrect performance range.

Which lots are affected?

Lot #: A6DLA001 Unique Device Identifier: 10711234170373

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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