Z-0082-2007

TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1...

Name: Z-0082-2007 TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1...
Creator: Tosoh Bioscience Inc
Published: 2006-09-01
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2006-09-01 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box on 2006-09-01. The reason FDA records is "Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument". 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-0082-2007
Status: Terminated
Initiated: 2006-09-01
Posted: 2006-10-28
Terminated: 2007-07-21
Recalling firm: Tosoh Bioscience Inc
Product: TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box.
Product code: JIS Calibrator, Primary
Reason for recall: Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm mailed Urgent: Medical Device Recall letters to their customer accounts on 9/5/2006. The letter informs the customers of the calibration problem and asks that the customers examine their inventories for the presence of the suspect product and place any product found in quarantine. The letter also asks that the customers identify their subaccount/customers and notify them of the recall with a copy of the recall letter, if the product has been further distributed. The recall letter is accompanied by a Response form which the customer is asked to complete and return to TOSOH as soon as possible. The Response form requires reporting of infomation concerning the amount and disposition of all product on-hand. It also includes a section for use by the distributor/customers for indicating whether or not their customers have been notified as well as the names and addressed of the distributor''s subaccounts. Should the customer(s) have any questions, the recall letter provides a telephone number and the name of a contact person to whom questions can be addressed.
Quantity in commerce: 151 boxes
Distribution: Nationwide distribution ---- including states of AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TX, WA, WI, WV, and WY.
Product codes and lots: Lot Code: G431726 (shipped after June 6, 2006)

Product code JIS

K992365Class IIAia-Pack Folate AssayTosoh Medics, Inc. / cleared 1999-08-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)