FDA Medical Device Recalls (openFDA)
Accriva Diagnostics, Inc.: directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
- Recall number
- Z-2460-2026
- Recalling firm
- Accriva Diagnostics, Inc.
- Product
- directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
- Status
- Open, Classified
- Initiated
- 2026-04-30
- Posted
- 2026-06-16
- Terminated
- not on file
- Reason
- Assayed Whole blood control contains labeling with incorrect performance range.
- 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 techsupport.na@werfen.com.
- Quantity
- 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.
- Lot, serial or model codes
- Lot #: A6DLA001 Unique Device Identifier: 10711234170373
- 510(k) numbers
- K202101
- PMA numbers
- not on file
- Product code
- GGN
- Firm FEI
- 2250033
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28