Class II U.S. Food and Drug Administration

Aniara Diagnostica LLC 5-Plasma Bivalirudin Control 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

This is a specification failure: testing showed the product does not match what the label promises.

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-2896-2026
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
9 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 05070002420385, Lot Number: KE132602
UPC codes
05070002420385

Products covered by this recall

5-PLASMA Bivalirudin Control, Model Number 5D-44905

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.

  • 05070002420385

Lot or batch code

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

  • KE132602 — 9 units

Model or item number

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

  • 5D-44905 — 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 — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  3. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  4. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

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 05070002420385; lot code KE132602 — 9 units; model number 5D-44905 — 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?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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