CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

Sperm Ab Elisa (96 well plate test) recalled by DRG International

DRG International is recalling Sperm Ab Elisa (96 well plate test), distributed nationwide in the US. The recall was initiated on 2 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;

Quantity recalled211

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0082-2027
FDA event ID: 99799
Recalling firm: DRG International, Springfield, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 2 Jul 2026
FDA classified: 2 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Jul 2026	Recall initiated by company
2 Oct 2026	Classified by FDA	+92 days
14 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for false negative patient results.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.

Nationwide New Jersey

Questions about this recall

Why was it recalled?

Potential for false negative patient results.

Which lots are affected?

Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;

Where was it sold?

Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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