Z-2282-2016Class III

Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions...

Name: Z-2282-2016 Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions...
Creator: Tosoh Bioscience, Inc.
Published: 2016-06-07
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2016-06-07 / Terminated / root cause: labeling and UDI

FDA source

Tosoh Bioscience, Inc. began a recall of Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the... on 2016-06-07. FDA classified it as Class III and gives the reason as "Instructions For Use had incorrect lot number and calibrator values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2282-2016
Classification: Class III
Status: Terminated
Initiated: 2016-06-07
Posted: 2016-07-25
Terminated: 2017-02-22
Recalling firm: Tosoh Bioscience Inc
Product: Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Product code: JIT Calibrator, Secondary
Reason for recall: Instructions For Use had incorrect lot number and calibrator values
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Tosoh Bioscience sent an Urgent Correction Notification letter dated June 7, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Tosoh Technical Support at 1-800-248-6764.
Quantity in commerce: 41 single sets of Progesterone 3 calibrators
Distribution: US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Product codes and lots: Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2282-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2282-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25

Product code JIT

K153417Class IIST AIA-PACK PROG III Calibrator SetTosoh Bioscience, Inc. / cleared 2015-12-18

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)