FDA Medical Device Recalls (openFDA)
Tosoh Bioscience, Inc.: 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.
- Recall number
- Z-2282-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-06-07
- Posted
- 2016-07-25
- Terminated
- 2017-02-22
- Reason
- Instructions For Use had incorrect lot number and calibrator values
- 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
- 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.
- Lot, serial or model codes
- Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
- 510(k) numbers
- ["K153417"]
- PMA numbers
- not on file
- Product code
- JIT
- Firm FEI
- 1000123732
- Firm city
- South San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28