Class II U.S. Food and Drug Administration

DRG International, Inc. Sperm Ab ELISA recall: Potential for false negative patient results

Recall published 11 days ago

Potential for false negative patient results.

The hazard: Device malfunction

This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

What the notice says: Potential for false negative patient results.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

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-0082-2027
Published
October 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
DRG International, Inc.
Product type
Medical devices
Units affected
211
Distribution
Nationwide
Made in
United States
Lot / code info
Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
UPC codes
04048474018264

Products covered by this recall

Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

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.

  • 04048474018264

Lot or batch code

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

  • 320K046

Model or item number

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

  • EIA-1826

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 Malfunction

DRG International, Inc. — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  3. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  4. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: DRG International, Inc. — 841 Mountain Ave, Springfield, NJ, 07081-3437

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 DRG International, Inc. medical devices recalled?

Potential for false negative patient results. Potential for false negative patient results.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04048474018264; lot code 320K046; model number EIA-1826. 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?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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