ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI…
Tosoh Bioscience Inc · 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 c…
Open FDA's page for this record- Cfres ID
- 221069
- Product res number
- Z-2746-2026
- Event date initiated
- 2026-06-12
- Event date posted
- 2026-07-16
- Recall status
- Open, Classified
- Res event number
- 99210
- Product code
- CDZ
- Code info
- UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
- Firm FEI number
- 3005529799
- Recalling firm
- Tosoh Bioscience Inc
- Address 1
- 3600 Gantz Rd
- City
- Grove City
- State
- OH
- Postal code
- 43123-1895
- Additional info contact
- Isabelle Lang-Zwosta 615-8064671
- Root cause description
- Component design/selection
- Product quantity
- 310 units
- Distribution pattern
- Global Distribution. US Nationwide.
- Product description
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 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.
- Action
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.
- K numbers
- K023091
- Harmonized identifiers (openFDA)
- Device name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1680
- Device class
- 1
- K number
- K791999, K955870, K811536, K964889, K802661, K091867, K841948, K802728, K915823, K772191, K800776, K201908, K883267, K915570, K955102, K830512, K955440, K813401, K001935, K021326, K133491, K120009, K014120, K152185, K854674, K240865, K802135, K233480, K001086, K252728, K924257, K191350, K102814, K840187, K191533, K941797, K854671, K122793, K904100, K803001 +49 more
- Registration number
- 3002800697, 2032087, 9610126, 2432235, 3007361513, 8020888, 2032839, 1827821, 2245285, 8010132, 1219913, 3022178699, 9612316, 3005542422, 1832216, 2122870, 3007118747, 1319681, 1222302, 3005333358, 1036362, 3003559191, 8031673, 3005984081, 2032682, 1063851, 3002642396, 8023018, 9710337, 3009092698, 3003385757, 3007349751, 3004192065, 3006198300, 3002806944, 2029372, 8021924, 3005529799, 2018685, 1415939 +17 more
- FEI number
- 3002806808, 3002800697, 2432235, 3007361513, 1827821, 2245285, 3002485711, 3003261083, 1219913, 3022178699, 2122870, 3005542422, 1832216, 1000442352, 3007118747, 3005333358, 1036362, 3003559191, 1000306617, 3005984081, 3000717645, 3003355251, 3007019572, 2967, 3002642396, 3004185580, 3009092698, 3003385757, 3007349751, 3004192065, 3006198300, 3002806944, 3002808140, 3002806559, 3005529799, 2018685, 1415939, 2419955, 3033967997, 2517506 +17 more