Class III — Lab Vision Corporation
| Recalling firm | Vision Lab Co, LLC |
|---|---|
| Registered facility | VISION LAB CO, LLC (the firm's only registered facility) |
| Classification | Class III |
| 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. |
| 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,… |
| Quantity | 5 vials |
| Distribution | Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands. |
| Initiated | 2015-10-27 |
| Classified | 2015-11-20 |
| Terminated | 2016-07-07 |
| Recall number | Z-0322-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Lab Vision Corporation (Z-0322-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72537/
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