FDA Medical Device Recalls (openFDA)
Aniara Diagnostica LLC: 5-PLASMA Bivalirudin Control, Model Number 5D-44905
- Recall number
- Z-2896-2026
- Recalling firm
- Aniara Diagnostica LLC
- Product
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905
- Status
- Open, Classified
- Initiated
- 2026-07-01
- Posted
- 2026-08-05
- Terminated
- not on file
- Reason
- Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
- Root cause
- Process control
- Action
- Email notifications were sent to customers on 6/17/26. Please reply to this email as acknowledgment you have received this initial notification and please include the quantity of each product which is remaining in your possession. A notification letter dated 7/1/26 was sent to customers. Actions to be implemented: " Destroy all stock of 5-PLASMA Bivalirudin Control, 5-PLASMA Bivalirudin Calibrator, & 5-PLASMA AMR Verification Kits - Please permanently deface the box labels and vial labels before disposal. " Complete and return the Awareness Acknowledgement form. " If product has been consumed please add brief statement to the Comment section, complete the End User Information, and return the Awareness Acknowledgement form.
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
- Lot, serial or model codes
- UDI-DI: 05070002420385, Lot Number: KE132602
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GGN
- Firm FEI
- 3005017664
- Firm city
- West Chester
- Firm state
- OH
- 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