Clearview Hcg Cassette And Innovacon Hcg One Step Pregnancy Test Device

Recalling firm

Abbott Laboratories (NZ) Ltd

Product

Clearview hCG Cassette and Innovacon hCG One Step Pregnancy Test Device. [Device]. Model: Clearview™ hCG Cassette (20 mIU/mL), Innovacon™ hCG One Step Pregnancy Test Device (Urine). Affected: Part number: 92210, FHC-102 - All lots within expiration date

Reason

Update 2/9/26: In consideration of the current market shortage of the affected products, this action has been revised for distributors. Distributors may continue to supply inventory to their customers, on the provision that all future customer orders must be accompanied by the Urgent Product Correction Customer Letter and Customer Reply Form., As part of routine post-market surveillance activities, an investigation was conducted into reports of false-positive results, and determined that while the tests demonstrate expected results at and above the established sensitivity levels, they may...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-02

Status

Ongoing

Distribution

New Zealand - Healthcare Professional

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/e9b62487-2767-446c-8b56-54a7c1939399