CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report
G8 Automated HPLC Analyzer - 723G8 recalled by Tosoh Bioscience
Tosoh Bioscience is recalling G8 Automated HPLC Analyzer - 723G8, distributed nationwide in the US. The recall was initiated on 13 Jul 2018 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-3244-2018
- FDA event ID
- 80585
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jul 2018
- FDA classified
- 25 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Jul 2018 | Recall initiated by company | |
| 25 Sep 2018 | Classified by FDA | +74 days |
| 3 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Analyzers were distributed with software which lacks a 510K
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
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Where it was distributed
US Nationwide Distribution in states of - CA, OK, VA 7 WI
Questions about this recall
Is G8 Automated HPLC Analyzer - 723G8 recalled?
Yes. Tosoh Bioscience recalled G8 Automated HPLC Analyzer - 723G8 on 13 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3244-2018.
Why was it recalled?
Analyzers were distributed with software which lacks a 510K
Which lots are affected?
Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201
Where was it sold?
US Nationwide Distribution in states of - CA, OK, VA 7 WI
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.
More recalls from Tosoh Bioscience
All 74| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ST Aia-Pack Testosterone, IN Vitro Diagnostic Use Only recalled | Tosoh Bioscience | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Thyroglobulin Antibody (TgAB) Calibrator recalled by Tosoh Bioscience | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | Aia- Pack Hcg Calibrator Set-In Vitro Diagnostic for Bhcg recalled | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | Aia-pack Bhcg Calibration Verification Test Set-In Vitro recalled | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | AIA-900 Analyzer recalled by Tosoh Bioscience | Tosoh Bioscience | Lead & Heavy Metals | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |