CLASS III Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Program Update Package AutoDELFIA¿ 3.0, Fluorometer recalled
PerkinElmer Health Sciences is recalling Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number, 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-1101-2017
- 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
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 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: 649552 OUS: 649552, 649552
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 75949| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Delfia¿ PC with V3.0 recalled by PerkinElmer Health Sciences | 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 | Delfia¿ PC with V3.0 recalled by PerkinElmer Health Sciences | 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 2,661| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |