Recall Z-2038-2016— Cell Marque Corporation
Class II · Terminated
Class II FDA medical device recall by Cell Marque Corporation, initiated 2016-05-10, terminated 2016-09-23. It names one FDA 510(k) clearance: K133845. 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..
- Recalling firm
- Cell Marque Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-10
- Terminated
- 2016-09-23
- Firm location
- Rocklin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.