Z-1761-2017 Class II Terminated
FDA device recall Z-1761-2017 was initiated by PerkinElmer Life and Analytical Sciences, Wallac, OY on March 7, 2017 and is designated Class II. Reason for recall: Potential for errors in patient results generated by the Specimen Gate Laboratory Software. The recall status is terminated (terminated May 10, 2021). Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- May 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
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.
Distribution Pattern
Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
Code Information
Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2