Tosoh Bioscience Inc: 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

Recall number

Z-2746-2026

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

Status

Open, Classified

Initiated

2026-06-12

Posted

2026-07-16

Terminated

not on file

Reason

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

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) TESrecall@tosoh.com 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) TESrecall@tosoh.com

Quantity

310 units

Distribution

Global Distribution. US Nationwide.

Lot, serial or model codes

UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408

510(k) numbers

["K023091"]

PMA numbers

not on file

Product code

CDZ

Firm FEI

3005529799

Firm city

Grove City

Firm state

OH

Firm country

not on file

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

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