Recall Z-0775-2014 ยท MVU Reagents, Specific, Analyte
Lab Vision Corporation
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed b
| Date | Jan 16, 2014 (initiated Dec 6, 2013) |
| Status | Terminated |
| Reason | Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues. |
| Root cause | Under Investigation by firm |
| Action | Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in b |
| Quantity | 5 |
| Distribution | Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.