Cell Marque Recalls SIOOA I Rabbit Monoclonal Antibody Lots
Cell Marque is recalling specific lots of SIOOA I Rabbit Monoclonal Antibody due to unacceptable IHC test results. The affected units were distributed in the US and several international countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Cell Marque Corporation is recalling 23 units of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16. The recall was initiated because the company became aware that some lots exhibited an unacceptable IHC test result.
The affected product is intended for identifying associated antigens in formalin-fixed, paraffin-embedded tissue sections using IHC test methods. The specific lot codes involved are 1335409A, 1335409B, 1335409C, 1335409D, 1335409E, and 1335409F.
The product was distributed in the states of Massachusetts, California, and Washington, as well as in Australia, Denmark, Turkey, Germany, Russia, Slovenia, the Netherlands, and Zambia. Users should stop using the affected lots and contact Cell Marque Corporation for further instructions.
The recalled product
- Product
- SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test…
- Manufacturer
- Cell Marque Corporation
- Affected units
- 23
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 codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.
Distribution
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