Recall Z-1761-2017— PerkinElmer Life and Analytical Sciences, Wallac, OY
Class II · Terminated
Class II FDA medical device recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, initiated 2017-03-07, terminated 2021-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.. Reason: Potential for errors in patient results generated by the Specimen Gate Laboratory Software..
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-07
- Terminated
- 2021-05-10
- Firm location
- Turku, N/A, Finland
Product description
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
Reason for recall
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Data sourced from openFDA. This site is unofficial and independent of the FDA.