Dako North America, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Dako North America, Inc. makes
Dako North America, Inc. manufactures monoclonal antibodies for immunohistochemistry (IHC), including ready-to-use reagents targeting human estrogen receptor (ER) and progesterone receptor (PR) proteins, such as clones EP1, PgR 636, and SP1. It also produces diagnostic kits like PD-L1 IHC 28-8 PHARMDX for melanoma and C-Kit pharmDx for targeted biomarker detection.
These products fall under FDA-regulated Class II and Class III devices, with some authorised via the 510(k) pathway and others through the Premarket Approval (PMA) process. The company’s offerings are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
PD-L1 IHC 28-8 PHARMDX (Melanoma Indication) Ref P150027
Regimes: PMA Registry: PMAC-Kit pharmDx Ref P040011
Regimes: PMA, withdrawn Registry: PMA
FDA recalls
FDA recall records list 8 recalls initiated by Dako North America, Inc., the earliest on 2008-05-01 and the most recent on 2018-02-02. By recorded status: 8 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power, mechanical integrity, 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.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 2 Feb 2018 Z-2425-2018 Class II Terminated To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months.
2016
- 10 Jun 2016 Z-2099-2016 Class II Terminated An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
Full distribution text
- 10 Jun 2016 Z-2099-2016 Class II Terminated An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
2015
- 4 Sep 2015 Z-0220-2016 Class II Terminated There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
Full distribution text
- 1 Apr 2015 Z-1548-2015 Class II Terminated If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display the updated test with the requested change, but the Omnis system will execute the initial test, not reflecting the change. The system will not warn the user that the test request was rejected.
Full distribution text
- 12 Feb 2015 Z-1261-2015 Class II Terminated A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.
Full distribution text
- 4 Sep 2015 Z-0220-2016 Class II Terminated There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
2014
- 29 Aug 2014 Z-2708-2014 Class II Terminated Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may cause premature rejection of reagent bottles or inadequate aspiration of reagent if the instrument has also had a preventative maintenance or waste pump replacement, and the baseplate is not completely aligned.
Full distribution text
- 21 Jan 2014 Z-1093-2014 Class II Terminated Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
- 29 Aug 2014 Z-2708-2014 Class II Terminated Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may cause premature rejection of reagent bottles or inadequate aspiration of reagent if the instrument has also had a preventative maintenance or waste pump replacement, and the baseplate is not completely aligned.
2008
- 1 May 2008 Z-0287-2013 Class II Terminated Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
Full distribution text
- 1 May 2008 Z-0287-2013 Class II Terminated Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
Frequently asked questions
How many devices does Dako North America, Inc. have in the registry?
The registry currently lists 6 devices for Dako North America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dako North America, Inc.'s devices?
Among its 6 most recently registered devices, Dako North America, Inc. has devices listed in FDA 510(k) (4 devices) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Dako North America, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Dako North America, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Dako North America, Inc.?
FDA recall records list 8 recalls initiated by Dako North America, Inc., the most recent initiated on 2018-02-02. 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 Dako North America, Inc. in the registry?
The most recently registered devices listed for Dako North America, Inc. include FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link), MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK), MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI and MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634.