Lab Vision Corp.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 11
At a glance
Market reach
- United States
- FDA recalls
What Lab Vision Corp. makes
Lab Vision Corp. manufactures rabbit monoclonal anti-human progesterone receptor antibody (clone SP2) and rabbit monoclonal anti-human estrogen receptor antibody (clone SP1).
These devices are classified as Class II and are listed in the FDA 510(k) registry. The company is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 11 recalls initiated by Lab Vision Corp., the earliest on 2010-03-05 and the most recent on 2016-01-18. By recorded status: 11 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 18 Jan 2016 Z-0815-2016 Class III Terminated Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
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- 18 Jan 2016 Z-0815-2016 Class III Terminated Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
2015
- 27 Oct 2015 Z-0322-2016 Class III Terminated 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.
2013
- 6 Dec 2013 Z-0775-2014 Class II Terminated Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
2012
- 11 Jan 2012 Z-1083-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
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- 11 Jan 2012 Z-1084-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
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- 11 Jan 2012 Z-1085-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
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- 11 Jan 2012 Z-1086-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
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- 11 Jan 2012 Z-1087-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
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- 11 Jan 2012 Z-1088-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
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- 11 Jan 2012 Z-1089-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
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- 11 Jan 2012 Z-1083-2012 Not yet classified Terminated Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
Show all 11 recalls
2010
- 5 Mar 2010 Z-2424-2010 Unclassified (pre-2012) Terminated Two lots may be contaminated with Ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
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- 5 Mar 2010 Z-2424-2010 Unclassified (pre-2012) Terminated Two lots may be contaminated with Ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
Frequently asked questions
How many devices does Lab Vision Corp. have in the registry?
The registry currently lists 2 devices for Lab Vision Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lab Vision Corp.'s devices?
Among its 2 most recently registered devices, Lab Vision Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Lab Vision Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Lab Vision Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Lab Vision Corp.?
FDA recall records list 11 recalls initiated by Lab Vision Corp., the most recent initiated on 18 Jan 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Lab Vision Corp. in the registry?
The most recently registered devices listed for Lab Vision Corp. include NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) and NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1).