Recall Z-0322-2016 ยท NTR Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Lab Vision Corporation
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (p
| Date | Oct 27, 2015 |
| Status | Terminated |
| Reason | It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml. |
| Root cause | Labeling design |
| Action | The firm, ThermoFisher Scientific, sent an "URGENT MEDICAL DEVICE RECALL-Lab Vision Corporation" letter dated 10/29/2015 to its customers on 10/30/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to Upon identification of the affected lot, notify Lab Vision of the quantity previously used and the quantity still in inventory; review any associated test results to ensure an accurate diagnosis was able to be made; If routine laboratory use of this product follows the Lab Vision Data Sheet, the antibody may safely be used as is; hold any affec |
| Quantity | 5 vials |
| Distribution | Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.