CLASS III Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
PerkinElmer 226 Sample Collection Device recalled
PerkinElmer Health Sciences is recalling PerkinElmer 226 Sample Collection Device, distributed in Ohio. The recall was initiated on 19 Dec 2017 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-2264-2020
- FDA event ID
- 85630
- Recalling firm
- PerkinElmer Health Sciences, Greenville, SC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Dec 2017
- FDA classified
- 4 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Dec 2017 | Recall initiated by company | |
| 4 Jun 2020 | Classified by FDA | +898 days |
| 10 Jun 2020 | 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
PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Product as listed by the FDA
PerkinElmer 226 Sample Collection Device
Where it was distributed
US distribution in the state of Ohio
Questions about this recall
Why was it recalled?
PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Which lots are affected?
UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700
Where was it sold?
US distribution in the state of Ohio
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.
More recalls from PerkinElmer Health Sciences
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|---|---|---|---|---|---|
| Device | CLASS III | PerkinElmer 226 Sample Collection Device The PerkinElmer recalled | PerkinElmer Health Sciences | Other | AL |
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