CLASS III Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Delfia¿ PC with V3.0 recalled by PerkinElmer Health Sciences
PerkinElmer Health Sciences is recalling Delfia¿ PC with V3.0, distributed nationwide in the US. The recall was initiated on 21 Dec 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1102-2017
- FDA event ID
- 75949
- Recalling firm
- PerkinElmer Health Sciences, Waltham, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Dec 2016
- FDA classified
- 26 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Dec 2016 | Recall initiated by company | |
| 26 Jan 2017 | Classified by FDA | +36 days |
| 1 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 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
Where it was distributed
Worldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,
Questions about this recall
Why was it recalled?
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Which lots are affected?
Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2
Where was it sold?
Worldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 75949This product is part of a recall event; the main page for the event is Program Update Package AutoDELFIA¿ 3.0, Fluorometer recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Program Update Package AutoDELFIA¿ 3.0, Fluorometer recalled | PerkinElmer Health Sciences | Device Malfunction | Nationwide | |
| CLASS III | AutoDELFIA¿ Plate Processor , Fluorometer recalled | PerkinElmer Health Sciences | Device Malfunction | Nationwide |
More recalls from PerkinElmer Health Sciences
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | PerkinElmer 226 Sample Collection Device recalled | PerkinElmer Health Sciences | Other | OH |
| Device | CLASS III | PerkinElmer 226 Sample Collection Device The PerkinElmer recalled | PerkinElmer Health Sciences | Other | AL |
| Device | CLASS III | AutoDELFIA¿ Plate Processor , Fluorometer recalled | PerkinElmer Health Sciences | Device Malfunction | Nationwide |
| Device | CLASS III | Program Update Package AutoDELFIA¿ 3.0, Fluorometer recalled | PerkinElmer Health Sciences | Device Malfunction | Nationwide |
| Device | CLASS II | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports recalled | PerkinElmer Health Sciences | Device Malfunction | 12 states |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |