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 (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.

Recall number

Z-0322-2016

Recalling firm

Lab Vision Corporation

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.

Status

Terminated

Initiated

2015-10-27

Posted

not on file

Terminated

2016-07-07

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 affected material in quarantine until the new labels are received-affected product may also be returned to Lab Vision, and complete and return the attached Recall Return Response Acknowledgement & Receipt Form via email to: sarah.rickert@thermofisher.com or Fax to: 269-372-2674, Attn: Quality Assurance & Regulatory Affairs Manager. A new label with the correct concentration can be sent upon request, for relabeling of the product at the customers facility. If you have any questions, please contact Quality Assurance & Regulatory Affairs Manager at 269-544-5628 or sarah.rickert@thermofisher.com.

Quantity

5 vials

Distribution

Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands.

Lot, serial or model codes

Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016.

510(k) numbers

not on file

PMA numbers

not on file

Product code

NTR

Firm FEI

3000719701

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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