Exact FDA event identifier

Event 72537

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: October 27, 2015
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Lab Vision Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Recall number: Z-0322-2016
Initiated: October 27, 2015
Classification: Class III
Status: Terminated
Recalling firm: Lab Vision Corporation
Quantity: 5 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

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Inspect official wording and provenance

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.

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.