Agency classClass IIIOur severity:Low FDA (Devices)·Z-2627-2017·Announced 2017-07-05

Euro Diagnostica Recalls DIASTAT ANA Kits Due to Incorrect Expiration Date

Euro Diagnostica AB is recalling 501 units of DIASTAT ANA kits because the packaging displayed the original expiration date instead of the shortened one.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging labeling discrepancy regarding the expiration date, fitting the criteria for a Low severity score.

Plain-English summary

Euro Diagnostica AB is recalling 501 units of the DIASTAT(R) ANA (anti-Nuclear antibody) test kit, lot TS 3577. The product is a qualitative enzyme-linked immunosorbent assay (ELISA) used to detect anti-nuclear antibodies in human serum or EDTA plasma.

The recall was initiated because the kits were re-worked due to a shortened shelf-life. While an alert sticker was applied to the kit box to inform customers of the shortened shelf-life and reference a letter containing the new expiration date, the original kit box label remained in place. Consequently, the packaging displayed the original expiration date rather than the correct, shortened expiration date.

The affected units were distributed to Minnesota, Texas, Nebraska, Pennsylvania, Spain, Egypt, Pakistan, Nepal, and Canada. Customers should check their inventory for lot TS 3577 and verify the expiration date on the packaging against the information provided in the accompanying customer letter.

The recalled product

Product: DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) 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 (SS-A), La (SS-B)…
Manufacturer: Euro Diagnostica AB
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling
Affected units: 501

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

TS 3577

Distribution

Distributed in 4 states:

Same manufacturer · Euro Diagnostica AB

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Same hazard · mis labeling