Recall Z-2066-2015— Tosoh Bioscience, Inc.

Name: FDA recall Z-2066-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-10

Class III · Terminated

Class III FDA medical device recall by Tosoh Bioscience, Inc., initiated 2015-02-10, terminated 2015-10-01. It names one FDA 510(k) clearance: K011434. 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: 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..

Recalling firm: Tosoh Bioscience, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-02-10
Terminated: 2015-10-01
Firm location: South San Francisco, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K011434 — G7 AUTOMATED HPLC ANALYZERTosoh Medics, Inc.·cleared 2001-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.