Z-2038-2016 Class II Terminated
FDA device recall Z-2038-2016 was initiated by Cell Marque Corporation on May 10, 2016 and is designated Class II. 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. The recall status is terminated (terminated September 23, 2016). Affected quantity: 23 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2016
- Initiation Date
- May 10, 2016
- Termination Date
- September 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
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.
Distribution Pattern
Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
Code Information
Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.