Reported Feb 1, 2017 · Terminated
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235…
PerkinElmer Health Sciences, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PerkinElmer Health Sciences, Inc. · 940 Winter St · Waltham, MA · 02451-1457
Is this the product you have?
- AutoDELFIA¿ Plate Processor , Fluorometer
- for clinical use Product Number1235-5110
- Product UsageThe 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
- Lot codes and dates
- AutoDELFIA¿
- Plate Processor 1235-5110 UDI
(01)06438147334766(21)2352016
- Serial Number2352016 (US)
- Serial NumbersOUS:
- s/n
235201423520462352048235205423520562352059
- Amount recalled
- 1 unit (US) 6 (OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- MN
Why it was recalled
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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