CLASS II Device recall · Reported 4 Nov 2015 · FDA Enforcement Report
Perkin Elmer Specimen Gate, Screening Center recalled
Perkin Elmer Life Sciences is recalling Perkin Elmer Specimen Gate, Screening Center, distributed in Florida, Georgia, Nevada. The recall was initiated on 24 Aug 2015 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-0166-2016
- FDA event ID
- 72013
- Recalling firm
- Perkin Elmer Life Sciences, Turku, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2015
- FDA classified
- 26 Oct 2015
- Reported
- 4 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Aug 2015 | Recall initiated by company | |
| 26 Oct 2015 | Classified by FDA | +63 days |
| 4 Nov 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
Product as listed by the FDA
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Where it was distributed
US distribution to FL, GA, and NV; and Canada
Questions about this recall
Is Perkin Elmer Specimen Gate, Screening Center recalled?
Yes. Perkin Elmer Life Sciences recalled Perkin Elmer Specimen Gate, Screening Center on 24 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-0166-2016.
Why was it recalled?
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
Which lots are affected?
Software Version 1.6
Where was it sold?
US distribution to FL, GA, and NV; and Canada
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.
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