FDA Device recall Z-2038-2016
SIOOA I (EP I84) Rabbit Monoclonal Antibody
- FDA Device
- Class II
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class II recall of SIOOA I (EP I84) Rabbit Monoclonal Antibody by Cell Marque, citing 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 resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2038-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-10 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cell Marque |
| Distribution | CA, MA, WA |
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
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.
Identifiers
| code_info | Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2038-2016%22
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