Recall Z-0166-2016 ยท JQP Calculator/Data Processing Module, For Clinical Use
Perkin Elmer Life Sciences Inc
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
| Date | Aug 24, 2015 |
| Status | Terminated |
| Reason | It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect. |
| Root cause | Software design |
| Action | Perkin Elmer issued the Recall Letter on 8/24/15 delivered to the customer by email .Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures: Ensure all laboratory routine sample testing procedures are followed to avoid procedural anomalies. In the event a procedure anomaly occurs, review the final analytical result and the corresponding interpretation to confirm both are accurate before releasing the report. Once a PerkinElmer reporting error query is available, continue to run the query until the final correctiv |
| Quantity | 6 units |
| Distribution | US distribution to FL, GA, and NV; and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.