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U.S. Department of Health and Human Services

Class 2 Device Recall 5PLASMA

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 Class 2 Device Recall 5PLASMAsee related information
Date Initiated by FirmJuly 01, 2026
Date PostedAugust 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2894-2026
Recall Event ID 99344
Product Classification Calibrator, secondary - Product Code JIT
Product5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Code Information UDI-DI: 05070002420378, Lot Number: KE132603
FEI Number 3005017664
Recalling Firm/
Manufacturer		 Aniara Diagnostica LLC
7768 Service Center Dr
West Chester OH 45069-2442
For Additional Information ContactMichele Washing
513-505-5276
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionEmail 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 in Commerce4 units
DistributionUS Nationwide distribution in the states of IL, NC, TN.
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.
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