Z-2460-2026Class II

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

Name: Z-2460-2026 directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Creator: Accriva Diagnostics, Inc.
Published: 2026-04-30
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2026-04-30 / Open, Classified / root cause: manufacturing process

FDA source

Accriva Diagnostics, Inc. began a recall of directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 on 2026-04-30. FDA classified it as Class II and gives the reason as "Assayed Whole blood control contains labeling with incorrect performance range". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2460-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-30
Posted: 2026-06-16
Recalling firm: Accriva Diagnostics, Inc.
Product: directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Product code: GGN Plasma, Coagulation Control
Reason for recall: Assayed Whole blood control contains labeling with incorrect performance range.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 8, 2026 Accriva Diagnostics, issued a Urgent Medical Device Recall Notification to affected consignees via E-Mail.. Accriva asked consignees to take the following actions: 1. Please forward this communication to those within your organization who need to become aware 2. Forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3. Forward the enclosed customer notification to those in your organization that are responsible for performing quality control testing and/or supervise testing. 4. Please check your inventory to determine if you have any boxes of directCHECK Whole BloodControls. If you have this product in stock, do NOT use. 5. Please destroy all impacted boxes and document on the enclosed form. 6. Please read the instructions on the Tracking Form and complete and return the form to Accriva Diagnostics, Inc. 7. If you have any technical questions, please contact Technical Services at 1-800-678-0710 Option 3 or e-mail [email protected].
Quantity in commerce: 6060
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.
Product codes and lots: Lot #: A6DLA001 Unique Device Identifier: 10711234170373

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2460-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2460-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-16

Product code GGN

K202101Class IIGEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2Accriva Diagnostics, Inc. / cleared 2021-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)