CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report
EyeScan, A-Scan Biometer recalled by Sonogage
Sonogage is recalling Sonogage EyeScan, A-Scan Biometer, distributed nationwide in the US. The recall was initiated on 9 Aug 2013 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-2202-2013
- FDA event ID
- 66027
- Recalling firm
- Sonogage, Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Aug 2013
- FDA classified
- 16 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Aug 2013 | Recall initiated by company | |
| 16 Sep 2013 | Classified by FDA | +38 days |
| 25 Sep 2013 | 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
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Where it was distributed
Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA. Product was also shipped to Canada and Mexico.
Nationwide AlaskaArizonaCaliforniaFloridaGeorgiaIllinoisKentuckyLouisianaMassachusettsMarylandMinnesotaNebraskaNew JerseyNew MexicoNew YorkOhioOregonPennsylvaniaTexasVirginia
Questions about this recall
Is EyeScan, A-Scan Biometer recalled?
Yes. Sonogage recalled EyeScan, A-Scan Biometer on 9 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2202-2013.
Why was it recalled?
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
Which lots are affected?
Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444, ES10446 - ES10472, ES10474, ES10476 - ES10478, ES10481 - ES10483, ES10485 - ES10508, ES10510, ES10512 - ES10529, ES10531 - ES10543, ES10545 - ES10546, ES10548 - ES10558, ES10560 - ES10566, ES10568 - ES10570, ES1059, T10217 & T80002-T80020.
Where was it sold?
Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA. Product was also shipped to Canada and Mexico.
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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