Euro Diagnostica AB: DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immun

Is my product affected?

DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (S

• UPC 07340058410486

Check against the official notice below — it lists the full affected range.

What happened

Euro Diagnostica AB is recalling 1,090 units of its DIASTAT anti-nuclear antibody (ANA) ELISA test kits with catalog number FANA200, specifically lot numbers SS 1500 and SS 2009. The product was distributed nationwide in the US and worldwide. The recall was initiated because an investigation found that although the kits met quality requirements at release, high background in the ELISA plate, a strong IgM conjugate, and a low reference control created an increased risk of equivocal and false positive test results.

The record does not specify a remedy or what affected consumers should do with the recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.

Details from the source

Reason for recall: Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009. Distribution: Worldwide Distribution and US. Nationwide Quantity: 1090 Lot/code info: UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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