Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Specimen Gate Laboratory

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Specimen Gate Laboratory see related information
Date Initiated by Firm March 07, 2017
Date Posted March 13, 2017
Recall Status1 Terminated 3 on May 10, 2021
Recall Number Z-1761-2017
Recall Event ID 76648
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
Code Information Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2
Recalling Firm/
Manufacturer		 PerkinElmer Life and Analytical Sciences, Wallac, OY
Mustionkatu 6
P.O. Box 10
Turku Finland
For Additional Information Contact Kay Taylor
317-4181735
Manufacturer Reason
for Recall		 Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
FDA Determined
Cause 2		 Software design
Action PerkinElmer Life and Analytical Sciences sent an Urgent Medical Device Correction letter dated March 7, 2017, to all affected consignees. The letter contains the following instructions: Until PerkinElmer's corrective measures are completed, we request our customers to close the Specimen Gate Laboratory Result Viewer between viewing and especially between manually calculating assay results. Closing and reopening the Result Viewer between processing the results from different assays effectively prevents the described issues from occurring. We also request our customers to follow unreported specimens with available tools to avoid any delay in reporting screening results. The available tools will vary depending on their process or the LIMS system that is used for activities associated with management of patient demographics, patient reports and the overall management of data generated from newborn screening testing. The final corrective action will involve an installation update to the software. PerkinElmer will deploy an installation update that will prevent the described issue when assays are calculated during the same Result Viewer session without closing it between the processing of different assays. Once the installation update is available, Software Services will contact you and arrange for the deployment. The installation update will be provided to you free of charge. Customers were instructed to complete the enclosed response form and return it by fax to 1-330-825-8520 (US) =358 2 2678 357 (OUS). For questions regarding this recall call 317-418-1735.
Quantity in Commerce 29
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-