Recall Z-1830-2013— Tosoh Smd Inc

Name: FDA recall Z-1830-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-15

Class II · Terminated

Class II FDA medical device recall by Tosoh Smd Inc, initiated 2013-05-15, terminated 2013-11-27. It names one FDA 510(k) clearance: K971103. Product: AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.. Reason: Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers..

Recalling firm: Tosoh Smd Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Terminated: 2013-11-27
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.·cleared 1997-06-27

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 Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.

Reason for recall

Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.

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