Ebvp3 Entericbio Viral Panel 3, Molecular, 120 Tests

Recall Summary The EBVP3 EntericBio Viral Panel 3 test kit (lot numbers 25878, 26610, and 26644) is being recalled because some pouches were not properly heat-sealed during packaging due to operator error. Incompletely sealed pouches may produce invalid test results or fail quality checks. This device was distributed to hospitals, pharmacies, and laboratories in New Zealand.

Recalling firm

Ngaio Diagnostics Ltd

Product

EBVP3 EntericBio Viral Panel 3, molecular, 120 tests. [Device]. Model: Affected lot number - 25878. Affected: Additional (lot # 26610 and 26644)

Reason

A manufacturing operator error was identified during packaging of the EntericBio® Viral Panel pouches, the operator did not follow the approved Standard Operating Procedure (SOP), resulting in pouches not being fully heat sealed. This led to incomplete package seals. The issue was identified as an operator error due to non-compliance with the established manufacturing procedure., The risk is that the pouches are not fully heal sealed causing invalid results and increase number of IAC failures.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-07-15

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/39d54ea4-4d3f-417a-aefe-5ef35ad20d67