CLASS II ONGOING Device recall · Reported 8 May 2019 · FDA Enforcement Report
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic recalled
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin, distributed nationwide in the US. The recall was initiated on 10 Jan 2019 and the FDA has classified it as Class II.
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-1239-2019
- FDA event ID
- 82064
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jan 2019
- FDA classified
- 26 Apr 2019
- Reported
- 8 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Jan 2019 | Recall initiated by company | |
| 26 Apr 2019 | Classified by FDA | +106 days |
| 8 May 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Product as listed by the FDA
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
Where it was distributed
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Questions about this recall
Is AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin recalled?
Yes. PerkinElmer Life and Analytical Sciences, Wallac, OY recalled AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin on 10 Jan 2019. The recall is Class II and its status is Ongoing. Recall number Z-1239-2019.
Why was it recalled?
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Which lots are affected?
Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303
Where was it sold?
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PerkinElmer Life and Analytical Sciences, Wallac, OY
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic recalled | PerkinElmer Life and Analytical Sciences, Wallac, OY | Other | Nationwide |
| Device | CLASS II | Delfia¿ hCG Kit, In Vitro Diagnostic recalled by PerkinElmer Life and | PerkinElmer Life and Analytical Sciences, Wallac, OY | Other | Nationwide |
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