FDA Medical Device Recalls (openFDA)
Tosoh Bioscience Inc: Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
- Recall number
- Z-2967-2020
- Recalling firm
- Tosoh Bioscience Inc
- Product
- Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
- Status
- Terminated
- Initiated
- 2020-08-07
- Posted
- 2020-09-14
- Terminated
- 2021-06-21
- Reason
- Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
- Root cause
- Under Investigation by firm
- Action
- The firm, Tosoh Bioscience, issued an "URGENT: MEDICAL DEVICE RECALL" Letter dated August 7, 2020 via Fedex to its customers. The letter states reason for recall, health risk and action to taken: Check the lot numbers of the AIA - PACK HCG Calibrator Set and AIA-PACK HCG Calibration Verification Test Set against the lot numbers listed above. Lots not listed above are not within the scope of this recall and maybe used per AAM. Remove all affected AIA - PACK HCG Calibrator Sets and AIA - PACK HCG Calibration Verification Test Sets from your inventory. The products must be tallied including previously used sets of the affected lots and properly destroyed per your local procedures and regulations. For reimbursement of destroyed calibrator and linearity sets, please contact Technical Support. Reimbursement will be with same or similar products. Review the information in this notification with the Medical Director and/or Lab Director as soon as possible and review the content of this letter with your laboratory staff Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651 or Email: biorecallresponse@tosoh.com or by US Post Mail: Be sure to indicate destruction of affected product(s). Tosoh Bioscience Inc. 3600 Gantz Rd. Grove City, OH 4312. Maintain this notification with your laboratory records and forward this information to others in your laboratory. If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
- Quantity
- 289 boxes
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
- Lot, serial or model codes
- Lot Numbers: J833531, JX33532, JZ33533, A233534, A433535
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIT
- Firm FEI
- 3005529799
- Firm city
- Grove City
- Firm state
- OH
- 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