Device product
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 (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
Z-0322-2016
Product summary
- Event
- Event 72537
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 vials
- Official record key
device-enforcement:Z-0322-2016
Official wording
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.
Code information: Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016.
Distribution pattern: Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands.
Derived failure modes
-
Unknown
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.