Z-2968-2020Class II

Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part...

Name: Z-2968-2020 Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part...
Creator: Tosoh Bioscience Inc
Published: 2020-08-07
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2020-08-07 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is... on 2020-08-07. FDA classified it as Class II and gives the reason as "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%". 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-2968-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-07
Posted: 2020-09-14
Terminated: 2021-06-21
Recalling firm: Tosoh Bioscience Inc
Product: Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: 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 tag: manufacturing process
FDA 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: [email protected] 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 [email protected]. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in commerce: 39 boxes
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
Product codes and lots: Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2968-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2967-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-14
Z-2968-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-14

Product code JJX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)