FDA Medical Device Recalls (openFDA)
Tosoh Bioscience, Inc.: 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.
- Recall number
- Z-2066-2015
- Recalling firm
- Tosoh Bioscience, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-02-10
- Posted
- 2015-07-14
- Terminated
- 2015-10-01
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764.
- Quantity
- 9 boxes/5 pouches
- Distribution
- Us Nationwide Distribution in the state ID including PR.
- Lot, serial or model codes
- Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015
- 510(k) numbers
- ["K011434"]
- PMA numbers
- not on file
- Product code
- LCP
- Firm FEI
- 1000123732
- Firm city
- South San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28