Recall Z-3244-2018 ยท LCP Assay, Glycosylated Hemoglobin
Tosoh Bioscience Inc
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.
| Date | Jul 13, 2018 |
| Status | Terminated |
| Reason | Analyzers were distributed with software which lacks a 510K |
| Root cause | No Marketing Application |
| Action | On July 13, 2018, Tosoh Bioscience started to telephone customers to set up on-site visits. On July 16, 2018, Tosoh Bioscience began to issue URGENT MEDICAL DEVICE RECALL notices to customers via hand delivery. Immediate Actions to be taken by the Customer/User: - Thoroughly review the content of this letter with the Tosoh field service representative. - Allow the Tosoh field representative to verify the software version currently on your analyzer - If the software is v5.23, your analyzer needs no further action - If the software is v5.24, allow the Tosoh field representative to download al |
| Quantity | 8 units |
| Distribution | US Nationwide Distribution in states of - CA, OK, VA 7 WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 Tosoh Bioscience, Inc., Jan 23, 2014 |