Z-0322-2016Class III

Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml)

Name: Z-0322-2016 Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml)
Creator: Lab Vision Corporation
Published: 2015-10-27
License: https://open.fda.gov/license/

Lab Vision Corp. / initiated 2015-10-27 / Terminated / root cause: labeling and UDI

FDA source

Lab Vision Corporation began a recall of 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... on 2015-10-27. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0322-2016
Classification: Class III
Status: Terminated
Initiated: 2015-10-27
Posted: 2015-11-20
Terminated: 2016-07-07
Recalling firm: Lab Vision Corp.
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.
Product code: NTR Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
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.
Root cause tag: labeling and UDI
FDA 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: [email protected] 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 [email protected].
Quantity in commerce: 5 vials
Distribution: Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands.
Product codes and lots: Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0322-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0322-2016	Class III	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-20

Product code NTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)