FDA Device recall Z-1004-2025

BD PCR Cartridges used with MAX System

• FDA Device
• Class II
• ongoing
• Published 2025-01-29

On 2025-01-29 the FDA classified a Class II recall of BD PCR Cartridges used with MAX System by Becton Dickinson And, citing potential for signal drift in specific lots of BD PCR Cartridges.

Read the official FDA Device notice

Product

BD PCR Cartridges used with MAX System. Model Number: 437519

Reason

Potential for signal drift in specific lots of BD PCR Cartridges.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1004-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.