Food, drugs, devices › Tosoh Bioscience, Inc.
Device recall: G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usa
FDA enforcement event 71493 is a device recall by Tosoh Bioscience, Inc. of South San Francisco, CA, initiated 10 Feb 2015 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 1 Oct 2015. Initiation: voluntary: firm initiated. Tosoh Bioscience, Inc. has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Tosoh Bioscience, Inc., South San Francisco, CA.
Reason for recall
"The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014."
Distribution
"Us Nationwide Distribution in the state ID including PR."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2066-2015 | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. | 9 boxes/5 pouches | Class III | Terminated | 22 Jul 2015 |
Context
Other enforcement events for Tosoh Bioscience, Inc.
All 27 events for Tosoh Bioscience, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Us Nationwide Distribution in the state ID including PR."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Oct 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.