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U.S. Department of Health and Human Services

Class 2 Device Recall directCHECK ACTLR whole blood quality control, level 2

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 Class 2 Device Recall directCHECK ACTLR whole blood quality control, level 2see related information
Date Initiated by FirmApril 30, 2026
Date PostedJune 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2460-2026
Recall Event ID 98979
510(K)NumberK202101 
Product Classification Plasma, coagulation control - Product Code GGN
Product directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Code Information Lot #: A6DLA001 Unique Device Identifier: 10711234170373
FEI Number 2250033
Recalling Firm/
Manufacturer		 Accriva Diagnostics, Inc.
6260 Sequence Dr
San Diego CA 92121-4358
For Additional Information ContactPaula Morgan
001-858-2632590
Manufacturer Reason
for Recall		Assayed Whole blood control contains labeling with incorrect performance range.
FDA Determined
Cause 2		Process control
ActionOn 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 techsupport.na@werfen.com.
Quantity in Commerce6060
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GGN
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