Recall Z-1100-2017— PerkinElmer Health Sciences, Inc.
Class III · Terminated
Class III FDA medical device recall by PerkinElmer Health Sciences, Inc., initiated 2016-12-21, terminated 2018-10-03. It names one FDA 510(k) clearance: K935047. Product: AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry. Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures.
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-12-21
- Terminated
- 2018-10-03
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Reason for recall
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Data sourced from openFDA. This site is unofficial and independent of the FDA.