Greiner Bio-One warns of isolated contamination in CRYO.S 2 ml cryo tubes
The Dutch inspectorate has published a manufacturer field safety notice after routine quality checks found isolated contamination in several lots of Greiner's CRYO.S 2 ml tubes.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a warning from Greiner Bio-One GmbH concerning its CRYO.S 2 ml cryo tubes. The manufacturer says its regular quality controls found that isolated instances of contamination may occur in various lots.
The product concerned is the CRYO.S 2 ML, SV NAT, with standing rim and 2D barcode. The Field Safety Notice (FSN) is dated 2 November 2026. The IGJ page carries a warning date of 6 November 2026 and links to a three-page PDF of the notice in English.
The IGJ page does not name the affected lot numbers, identify the contaminant, state how many tubes are involved or describe the corrective action. Those details are presumably in the linked notice, which the inspectorate's summary does not reproduce. Laboratories and biobanks using these tubes are the likely audience, since sample integrity could be compromised.
The IGJ explains that manufacturers must monitor medical devices after they reach the market and improve them where necessary. Where a risk to users arises, the manufacturer must act and inform both users and the inspectorate through a Field Safety Notice.
What it means for your team
- Labs and biobanks using Greiner CRYO.S 2 ml tubes with standing rim and 2D barcode should obtain the full FSN and check their stock against the affected lots.
- Quality teams should consider whether samples stored in these tubes could be affected and document their assessment, following the instructions in the manufacturer's notice.
- Regulatory and vigilance staff should note that this is a manufacturer-initiated notice published by the IGJ, and that the lot details and required actions are in the PDF rather than on the web page.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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