Recall Register

Lab Vision Corporation: FDA recalls

FDA enforcement reports name Lab Vision Corporation as the recalling firm in 3 events. The events have 3 product records. The recalls started from 2013 to 2016. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

3 events, newest first.

FDA enforcement events of Lab Vision Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
18 Jan 2016CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description – Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin…DeviceClass III1Terminated
27 Oct 2015Thermo 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…DeviceClass III1Terminated
6 Dec 2013Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Lab Vision Corporation: events for each product type
TypeEvents
Device3
Lab Vision Corporation: events in each class
ClassEvents
Class III2
Class II1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Lab Vision Corporation, by the year that the recall started. The largest year is 2013, with 1 event.

Official channels

Cite this page

Recall Register. Lab Vision Corporation: FDA recalls. https://recallregister.com/firm/lab-vision-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Lab Vision Corporation have?
Class III: 2 events. Class II: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Lab Vision Corporation?
FDA event 73120, which the firm started on 18 Jan 2016. The first product in the record is: CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description – Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin…
How many FDA recalls of Lab Vision Corporation have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.