Recall Z-1761-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
PerkinElmer Life and Analytical Sciences, Wallac, OY
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.
| Date | Mar 13, 2017 (initiated Mar 7, 2017) |
| Status | Terminated |
| Reason | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. |
| Root cause | 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 spe |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.