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.
What this means for you
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), S
- Manufacturer
- Euro Diagnostica AB
- Hazard
- 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
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