Recall Z-2168-2017— Tosoh Bioscience, Inc.

Name: FDA recall Z-2168-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-08

Class III · Terminated

Class III FDA medical device recall by Tosoh Bioscience, Inc., initiated 2017-02-08, terminated 2019-02-08. It names one FDA 510(k) clearance: K981521. Product: AIA-PACK TPOAb CONTROL SET. Reason: The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label..

Recalling firm: Tosoh Bioscience, Inc.
Classification: Class III
Status: Terminated
Initiated: 2017-02-08
Terminated: 2019-02-08
Firm location: South San Francisco, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K981521 — AIA-PACK TPOAB ASSAYTosoh Medics, Inc.·cleared 1998-10-08

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

AIA-PACK TPOAb CONTROL SET

Reason for recall

The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

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