Thermo Scientific p21 WF1 Ab-3 — Class III medical device recall Z-0322-2016
Terminated recall by Lab Vision Corporation, reported 2015-12-02, distributed in CA, WA. It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0
| Recall number | Z-0322-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lab Vision Corporation, Fremont, CA, United States |
| Recall initiated | 2015-10-27 |
| Classified | 2015-11-20 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-07-07 |
| Distributed | CA, WA |
| Countries outside the US | DE, NL, RS |
| Quantity | 5 vials |
| Reason classes | labeling |
| Lot numbers | 230P1409A, 230P1409C |
| Expiration dates | 2016-09 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0322-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.