PlainRecordsST AIA-Pack Testosterone…
- 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…
- Status
- Ongoing
- Distribution
- Global Distribution. US Nationwide.
- Enforcement report date
- July 22, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- 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
- 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.
- Distribution pattern
- Global Distribution. US Nationwide.
- Quantity
- 310 units
- Codes and lots
- UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
- Recall started
- June 12, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Root cause (FDA)
- Component design/selection
- What the company told customers
- Tosoh Bioscience Inc. sent an URGENT: MEDICAL DEVICE RECALL letter dated 6/9/26 to customers. Customers are to SEGREGRATE and quarantine all affected lots in inventory. Affected product lot should not be used. CONTACT Tosoh Customer Service department at 1-866-527-3587 to arrange return of the affected product. For questions, contact Tosoh Technical Support TESrecall@tosoh.com or 1-800-248-6764. For replenishment of returned Testosterone test cups, contact Customer Service department at 1-866-527-3587. Replenishments will be with ST AIA-PACK Testosterone Assay Test Cups from new lots. If 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, contact Tosoh Technical Support at 1-800-248-6764 or TESrecall@tosoh.com Monday to Thursday 8:30AM-8:30PM EST Friday 8:30AM-7:30PM EST An URGENT: MEDICAL DEVICE RECALL: SECOND NOTIFICATION: dated 7/17/26 was sent to customers. The letter has additional language regarding the risks to health associated with the use of the affected lots. Instructions to customers are the same as in the first letter.
- Recall number
- Z-2746-2026
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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.”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, FDA enforcement report, 2026-07-22. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Radioimmunoassay, Testosterones And Dihydrotestosterone
This recall among the others
- FDA's enforcement report came 40 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-2746-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2746-2026, July 22, 2026. "ST AIA-Pack Testosterone." PlainRecords, https://plainrecords.com/recall/device/z-2746-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections