Immunoscan CCPlus test kit is an enzyme-linked… recallZ-2918-2018 · Euro Diagnostica AB · initiated Feb 14, 2016
Class II Terminated All recalls posted in August 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Euro Diagnostica AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Decreasing performance overtime.
FDA root cause category: Nonconforming Material/Component
What the company is doing
None
Recall details
- Recall number
- Z-2918-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 14, 2016
- Posted by the FDA
- Aug 23, 2018
- Recalling firm
- Euro Diagnostica AB
- Quantity
- 25 kits (US only)
- Product code
- NHX
- FDA submissions
- K091657
- Distribution
- Minnesota and Texas Foreign: Iran
Product description
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
Code information (models, lots, serial numbers)
Lot # RS 3092, SS 1737
Other devices under the same FDA submission
1 device cleared under K091657 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMUNOSCAN CCPlus RA-96PLUSSvar Life Science AB · Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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