CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report
Specimen Gate Laboratory recalled by PerkinElmer Life and
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling Specimen Gate Laboratory, distributed nationwide in the US. The recall was initiated on 7 Mar 2017 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-1761-2017
- FDA event ID
- 76648
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2017
- FDA classified
- 7 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 7 Mar 2017 | Recall initiated by company | |
| 7 Apr 2017 | Classified by FDA | +31 days |
| 19 Apr 2017 | 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
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
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
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
Where it was distributed
Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMissouriNevadaOhioOklahomaOregon
Questions about this recall
Is Specimen Gate Laboratory recalled?
Yes. PerkinElmer Life and Analytical Sciences, Wallac, OY recalled Specimen Gate Laboratory on 7 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1761-2017.
Why was it recalled?
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Which lots are affected?
Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2
Where was it sold?
Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
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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