Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error
Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits due to an incorrect distribution label. The kits were distributed in Minnesota.
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 indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the distributor name.
Plain-English summary
Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits. These kits are used to detect IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and plasma. The recall is due to a labeling error where the kits were incorrectly marked as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'
The affected lots are TS 2819 (kit) and TS 2841 (PC). The recall is limited to Minnesota. No illnesses or injuries have been reported in connection with this labeling error.
Healthcare providers and laboratories should stop using the affected lots and contact Euro Diagnostica AB for further instructions.
The recalled product
- Product
- is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM…
- Manufacturer
- Euro Diagnostica AB
- Hazard
- Affected units
- 6
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)
- Lot #'s: TS 2819 (kit) and TS 2841 (PC)
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Euro Diagnostica AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Euro Diagnostica AB
See all →- LowEuro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error
FDA (Devices) · 2018-08-29
- LowEuro Diagnostica Scl-70 ELISA Kits Recalled for Labeling Error
FDA (Devices) · 2018-08-29
- ModerateEuro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance
FDA (Devices) · 2018-08-29
- LowEuro Diagnostica Anti-Ro ELISA Kits Recalled for Incorrect Labeling
FDA (Devices) · 2018-08-29
- ModerateEuro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives
FDA (Devices) · 2018-03-14
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateEuro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance
FDA (Devices) · 2018-08-29
- ModerateIDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling
FDA (Devices) · 2012-10-17
- LowPhadia Varelisa Cardiolipin IgM Test Kits Recalled for Elevated Results
FDA (Devices) · 2012-09-05
- ModerateEuro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives
FDA (Devices) · 2018-03-14
- LowEuro Diagnostica Recalls DIASTAT ANA Kits Due to Incorrect Expiration Date
FDA (Devices) · 2017-07-05
- ModerateEuro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation
FDA (Devices) · 2018-01-10