Z-2746-2026Class II

ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in...

Name: Z-2746-2026 ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in...
Creator: Tosoh Bioscience Inc
Published: 2026-06-12
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2026-06-12 / Open, Classified / root cause: design

FDA source

Tosoh Bioscience Inc began a recall of ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers... on 2026-06-12. FDA classified it as Class II and gives the reason as "The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2746-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-12
Posted: 2026-07-16
Recalling firm: Tosoh Bioscience Inc
Product: ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Reason for recall: The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
Root cause tag: design
FDA root cause: Component design/selection
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 6/9/26 was sent to customers. Immediate Actions to be taken by the Customer 1. REVIEW your inventory for the affected lots. 2. COMMUNICATE and review the information in this notification with the Medical Director and/or Lab Director and with others in your laboratory staff as soon as possible. 3. MAINTAIN this notification with your laboratory records and forward this notification to others in your laboratory staff 4. SEGREGRATE and quarantine all affected lots upon review of your inventory. Affected product lot should not be used. 5. COMPLETE and return the attached acknowledgement form to Tosoh Bioscience Inc. within 15 days of receiving this notification whether you have affected lots or not. Instructions for return of your remaining product to Tosoh Bioscience Inc. are stated below. Return of Product and Available Assistance: CONTACT the Tosoh Customer Service department at 1-866-527-3587 to arrange return of the affected product. Since this recall might affect availability of the product on the market, we will only be able to accommodate limited order quantities. Representatives can also answer questions related to replacements. For questions related to this notification and/or acknowledgement form that are not adequately addressed in the letter, please contact by (email) [email protected] or call Tosoh Technical Support (phone) 1-800-248-6764. Replenishment of Product: For replenishment of returned Testosterone test cups, please contact Customer Service department at 1-866-527-3587. Replenishments will be with ST AIA-PACK Testosterone Assay Test Cups from new lots Additional Information: In the event that you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the ST AIA-PACK Testosterone Assay Test Cups and associated Testosterone reagents, please contact Tosoh Technical Support (phone) 1-800-248-6764 (email) [email protected]
Quantity in commerce: 310 units
Distribution: Global Distribution. US Nationwide.
Product codes and lots: UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2746-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2746-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-16

Product code CDZ

K023091Class ISt Aia-Pack Testosterone AssayTosoh Medics, Inc. / cleared 2002-12-17

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)