The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
Reason for recall: The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing. Distribution: Distribution US nationwide, Canada, New Zealand, and Hong Kong. Quantity: 2,196,000 Lot/code info: UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.
50382903670012, 30382903670018, 00382903670017
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.