Beckman Coulter flags reversed calibration values on Access HIV Ag/Ab Combo Calibrator barcode
The manufacturer's internal investigation found the 2D barcode on the calibration card for certain lots assigns calibration values the wrong way round, prompting a field safety notice.
Beckman Coulter has told users of its Access HIV Ag/Ab Combo Calibrator that the 2D barcode on the calibration card supplied with certain lots contains reversed assignments of calibration values. The company identified the problem through an internal investigation, according to a notice published by the Dutch health inspectorate, IGJ.
The manufacturer's field safety notice (FSN) is dated 23 October 2026. The IGJ posted the item with a document headed as a warning dated 3 November 2026, a four-page PDF. The affected lot numbers are listed in the manufacturer's document rather than in the summary text of the inspectorate page.
The product is a calibrator used with the Access HIV Ag/Ab Combo assay. The source does not describe the specific consequences or say whether any incidents have been reported. In general, an incorrect calibration can affect the accuracy of test results, so laboratories are expected to follow the manufacturer's corrective instructions for the lots concerned.
As regulatory context, manufacturers of medical devices, including in vitro diagnostics, must monitor products after they reach the market and act where a risk to users emerges. They inform users and the competent authority through a field safety notice.
What it means for your team
- Laboratories using the Access HIV Ag/Ab Combo Calibrator should check their lot numbers against the list in Beckman Coulter's FSN and follow its corrective instructions.
- Quality teams may wish to review calibration records for the affected lots and document the actions taken, in line with internal procedures.
- Regulatory and vigilance staff should note the FSN date of 23 October 2026 and the IGJ publication of 3 November 2026 when tracking the field action.
- The source gives no details of patient impact or reported incidents, so teams should rely on the manufacturer's full notice for risk information.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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