Class II U.S. Food and Drug Administration

Instrumentation Laboratory The product is used for the evaluation of the intrinsic recall: Potential for microbial contamination

Recall published 9 months ago

Potential for microbial contamination.

The hazard: Microbial contamination

The problem here is microbial contamination, so the recall covers the production codes listed rather than the brand as a whole.

What the notice says: Potential for microbial contamination.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

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-1095-2026
Published
January 21, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Instrumentation Laboratory
Product type
Medical devices
Units affected
7,720 units
Distribution
Nationwide
Made in
United States
Lot / code info
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.

Products covered by this recall

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • 31
  • 2025. — 7
  • 720 units

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12
  • 31
  • 2025. — 7
  • 720 units

Model or item number

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

  • 0020006800. 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 Contamination

Instrumentation Laboratory — The problem here is microbial contamination, so the recall covers the production codes listed rather than the brand as a whole.

  1. Stop eating it and keep it separate from other food.
  2. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  3. Bag and bin it, or return it to the store for a refund.
  4. Clean and sanitise the fridge shelf, container or surface it was stored on.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Instrumentation Laboratory — 180 Hartwell Rd, Bedford, MA, 01730-2443

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 Instrumentation Laboratory medical devices recalled?

Potential for microbial contamination. Potential for microbial contamination.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 31, 2025. — 7, 720 units; best-by date 12 or 31; model number 0020006800. 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?

Stop eating it and keep it separate from other food.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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