Z-1830-2013Class II

AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag...

Name: Z-1830-2013 AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag...
Creator: Tosoh Smd Inc
Published: 2013-05-15
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2013-05-15 / Terminated / root cause: manufacturing process

FDA source

Tosoh Smd Inc began a recall of 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... on 2013-05-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1830-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Posted: 2013-07-30
Terminated: 2013-11-27
Recalling firm: Tosoh Bioscience Inc
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.
Product code: KHO Fluorometer, For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Tosoh Bioscience sent an Urgent Recall Notification letter dated May 15, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to respond on the amount of product that was destroyed by completing the attached form and faxing it to 614-317-1941. Customers with questions were instructed to call Tosoh Technical Support at 1-800-248-6764. For questions regarding this recall call 614-317-1909.
Quantity in commerce: 11,309 bags
Distribution: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.
Product codes and lots: The following lots numbers are affected by this recall: 060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1830-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1830-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-30

Product code KHO

K971103Class IAia Nexia-Automated Enzyme Immunoassay SystemTosoh Medics, Inc. / cleared 1997-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)