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Lower risk Medical device recall · FDA · Published March 5, 2018

Tosoh ST-AIA PACK Testosterone Recall: False Assay Results Risk

Tosoh Bioscience recalls ST-AIA PACK Testosterone (Part 025204) due to potential false test results. Affected units may cause inaccurate hormone measurements.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2093-2018Medical deviceTosoh Bioscience ›
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Contact the company

Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
✎ GovInfoNow plain-language explainer

Tosoh Bioscience is recalling its ST-AIA PACK Testosterone assay kit (Part Number 025:204) because it can produce false high or low results when used with Asfotase Alfa (Strensiq) treatments. This could lead to incorrect hormone level assessments for patients. Read more at govinfonow.com/recall/71769-tosoh-st-aia-pack-testosterone-recall-false-assay-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71769-tosoh-st-aia-pack-testosterone-recall-false-assay-results-risk · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2093-2018

Cite this page

“Tosoh ST-AIA PACK Testosterone Recall: False Assay Results Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71769-tosoh-st-aia-pack-testosterone-recall-false-assay-results-risk. Based on FDA recall #Z-2093-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2093-2018%22&limit=1).

The FDA announced on March 5, 2018, that Tosoh Bioscience Inc voluntarily recalled its ST-AIA PACK Testosterone Assay due to potential interference from Asfotase Alfa. This interference may cause falsely increased or decreased immunoassay test results.

How to tell if you have it

  • Brand: Tosoh Bioscience
  • Product: ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
  • Lot Codes: All Lot Codes
  • Quantity: 10913 units

The hazard

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Context

GovInfoNow's records show Tosoh Bioscience Inc has 19 other recalls on record since June 11, 2017. Other recent recalls of similar products include Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026), Tosoh AIA-Pack BHCG Calibrator Recall (August 7, 2020), and Tosoh AIA-900 Analyzer Recall (May 22, 2020). Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (July 6, 2026), Diagnostica Stago Asserachrom HPIA Kit Recall (December 15, 2025), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).

How to tell if you have this one

Check for the ST-AIA PACK Testosterone assay kit with Part Number 025204. All lot codes are affected. This product is sold by Tosoh Bioscience.

  • Brand
    Tosoh Bioscience
  • Category
    Medical device
FDA recall event · 35 products

All 35 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Recall numberProduct, codes & lotsQuantity
Z-2065-2018ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker; All Lot Codes3254
Z-2066-2018ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker; All Lot Codes15942
Z-2067-2018ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker; All Lot Codes41105
Z-2068-2018ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate; All Lot Codes1083
Z-2069-2018ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker; All Lot Codes4824
Z-2070-2018ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker; All Lot Codes12361
Z-2071-2018ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker; All Lot Codes2549
Z-2072-2018ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker; All Lot Codes733
Z-2073-2018ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker; All Lot Codes5802
Z-2074-2018ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes; All Lot Codes1358
Z-2075-2018ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes; All Lot Codes2982
Z-2076-2018ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes; All Lot Codes9625
Z-2077-2018AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid; All Lot Codes5293
Z-2078-2018ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid; All Lot Codes10424
Z-2079-2018ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid; All Lot Codes14690
Z-2080-2018ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid; All Lot Codes12055
Z-2081-2018ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid; All Lot Codes43275
Z-2082-2018ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid; All Lot Codes5491
Z-2083-2018ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone; All Lot Codes12614
Z-2084-2018ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone; All Lot Codes66
Z-2085-2018ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone; All Lot Codes1442
Z-2086-2018ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone; All Lot Codes9033
Z-2087-2018ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone; All Lot Codes4867
Z-2088-2018ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone; All Lot Codes16080
Z-2089-2018ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone; All Lot Codes49
Z-2090-2018ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone; All Lot Codes10023
Z-2091-2018ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone; All Lot Codes5990
Z-2092-2018ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone; All Lot Codes539
Z-2093-2018ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone; All Lot Codes10913
Z-2094-2018ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic; All Lot Codes4027
Z-2095-2018ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic; All Lot Codes752
Z-2096-2018ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia; All Lot Codes24410
Z-2097-2018ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy; All Lot Codes2867
Z-2098-2018ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker; All Lot Codes3406
Z-2099-2018ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker; All Lot Codes1047
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Verify the product name and part number on the kit to confirm it matches the recalled ST-AIA PACK Testosterone (Part 025204).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Mar 5, 201812. FDA classified it Class II: Jun 5, 201823. Published in FDA’s Enforcement Report: Jun 13, 201834. FDA terminated the recall: Aug 31, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Does this recall affect my Strensiq treatment?

The recall specifically addresses the testosterone assay kit used with Strensiq treatments. If you use this kit with Strensiq, you may need to switch to an alternative test.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2093-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2093-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA