G7 Variant Elution Buffer HiS no — Class III medical device recall Z-2066-2015
Terminated recall by Tosoh Bioscience, Inc., reported 2015-07-22, distributed nationwide. The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. Th
| Recall number | Z-2066-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience, Inc., South San Francisco, CA, United States |
| Recall initiated | 2015-02-10 |
| Classified | 2015-07-14 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2015-10-01 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | H7-111W |
| Model numbers | 021446 |
| Expiration dates | 2015-10 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2066-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.