CLASS II Device recall · Reported 13 Aug 2014 · FDA Enforcement Report
PerkinElmer Specimen Gate Screening Center recalled
PerkinElmer Health Sciences is recalling PerkinElmer Specimen Gate Screening Center, distributed in Florida, Georgia, Massachusetts, Nevada. The recall was initiated on 27 Jun 2014 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-2166-2014
- FDA event ID
- 68670
- Recalling firm
- PerkinElmer Health Sciences, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2014
- FDA classified
- 7 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 27 Jun 2014 | Recall initiated by company | |
| 7 Aug 2014 | Classified by FDA | +41 days |
| 13 Aug 2014 | 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
Potential for demographic information and test result to be mismatch.
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
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
Where it was distributed
Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
Questions about this recall
Why was it recalled?
Potential for demographic information and test result to be mismatch.
Which lots are affected?
Product Code: 5002-0500; Software Versions, 1.4 and 1.6
Where was it sold?
Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
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 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.
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