Quality & complianceOfficial

Immucor Panocell-20 lot 37605 shipped with wrong Master List for donor cell 6

🇳🇱 IGJ · Sun 08 Nov 2026

The Dutch health inspectorate has published a manufacturer warning: the Master List supplied with one Panocell-20 lot lists cell 6 as Jk(b+) when it is actually Jk(b-).

The Dutch healthcare inspectorate, IGJ, has published a manufacturer warning on Immucor's Panocell-20 red cell panel. Lot 37605 of the product (article number 0005020) was packaged with an incorrect Master List.

The error concerns cell 6, from donor C7935. The Master List shows the donor as Jk(b+), but the correct antigen typing is Jk(b-). The Jk(b) antigen belongs to the Kidd blood group system.

The IGJ summary says the discrepancy could lead to misinterpretation of red cell antibody screening or identification results. Affected users are advised to check the lot concerned and the corrected Master List.

The notice comes from the manufacturer, Immucor, Inc., whose authorised representative is Immucor Medizinische Diagnostik GmbH. The Field Safety Notice (FSN) is dated 21 October 2026. IGJ's page links to a three-page PDF warning.

As general context, manufacturers of medical devices must monitor products on the market and act where a risk to users arises. They inform users and the authorities through a Field Safety Notice. The source text does not describe any further corrective measures beyond the corrected Master List.

What it means for your team

  • Laboratories using Panocell-20 should check whether they hold lot 37605 and compare the Master List supplied with the corrected version.
  • Any Kidd-system (Jk(b)) antibody screening or identification results obtained with cell 6 of this lot may warrant review.
  • Quality teams should document receipt of the FSN and any review undertaken, in line with their vigilance procedures.
  • The source does not state whether other lots are affected or whether patient harm has been reported.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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