Class II U.S. Food and Drug Administration

Aniara Diagnostica LLC 5-Plasma Bivalirudin Calibrator recall: Stability issues with the reconstituted lyophilized human plasma

Recall published 2 months ago

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.

The hazard: Potency, impurity or stability failure

An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

What the notice says: 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.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2895-2026
Published
August 12, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Aniara Diagnostica LLC
Product type
Medical devices
Units affected
7 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 05070002420392, Lot Number: KE132601
UPC codes
05070002420392

Products covered by this recall

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05070002420392

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • KE132601 — 7 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 5D-46905 — UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Aniara Diagnostica LLC — An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  3. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  4. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Aniara Diagnostica LLC — 7768 Service Center Dr, West Chester, OH, 45069-2442

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Aniara Diagnostica LLC medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05070002420392; lot code KE132601 — 7 units; model number 5D-46905 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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