SIOOA I — Class II medical device recall Z-2038-2016
Terminated recall by Cell Marque Corporation, reported 2016-06-29, distributed in CA, MA, WA. Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-1
| Recall number | Z-2038-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cell Marque Corporation, Rocklin, CA, United States |
| Recall initiated | 2016-05-10 |
| Classified | 2016-06-17 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2016-09-23 |
| Distributed | CA, MA, WA |
| Countries outside the US | AU, DE, DK, NL, RU, SI, TR |
| Quantity | 23 units |
| Lot numbers | 1335409A, 1335409B, 1335409C, 1335409D, 1335409E, 1335409F |
| Model numbers | 408R-14, 408R-15, 408R-16, 470361 |
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 methods.
Reason for recall
Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2038-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.