AIA-900 Analyzer
Medical device recall Z-2423-2020. Published in FDA’s Enforcement Report on Jul 1, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 1, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 529 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
529, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
From customer letter: Serial numbers 10030810; 10101008; 10142204; 10212411; 10253902; 10263902 and higher serial numbers Complete list: (Distributed in US) 10030810 10050912 10071402 10101008 10142204 10162305 10202911 10212411 10222312…
Every code shown here, 1,997 characters
From customer letter: Serial numbers 10030810; 10101008; 10142204; 10212411; 10253902; 10263902 and higher serial numbers Complete list: (Distributed in US) 10030810 10050912 10071402 10101008 10142204 10162305 10202911 10212411 10222312 10253902 10263902 10273002 10303104 10303904 10313105 10313605 10333005 10333906 10343006 10343307 10353507 10353607 10353707R 10353807 10353907 10363507 10363608 10373108 10373408 10373508 10393108 10393208 10393308 10393908 10413009 10413509 10423409 10423909 10433009 10443110 10443210 10443310 10443710 10453310 10453410 10453810 10453910 10463010 10463110 10473111 10473211 10473311 10473411 10483411 10483511 10493111 10493411 10493711 10493911 10503011 10503111 10503211 10503311 10503612 10503912 10513412 10523912 10533012 10533112 10533212 10533412 10533612 10543012 10543212 10543412 10543512 10574301 10574601 10584702 10594502 10594602 10594702 10604902R 10614002 10614102 10614202 10614302 10624903 10634203 10634403 10634503 10644503 10644604 10644704 10644804 10644904 10654404 10654704 10654804 10654904 10664004 10664204 10674705 10674805 10684005 10684105 10684205R 10684405 10694406 10694606 10694706 10694806 10704006 10704807 10704907 10714007 10714107 10714207 10714307 10714407 10714507 10724808 10724908 10734008 10734108 10744509 10744709 10764310 10764410 10764510 10764610 10764710 10784111 10784411 10784511 10794011 10794111 10794211 10794311 10794411 10804312 10804412 10804612 10804712 10804812 10814012 10825701 10825801 10825901R 10835001 10835201 10855603 10855703 10855803 10865104 10865204 10865304 10865404 10885106 10885206 10885306 10885406 10895506 10895707 10895807 10895907 10905007 10905107 10905507 10905607 10905707 10905807 10905907 10915108 10915208 10925508 10935209 10975711 11036605 11036805 11036905 11046005 11046105 11046305 11046405 11046505 11046606 11046706 11066108 11066208 11066408 11066609 11066709 11066909 11076009 11076109 11076309 11076409 11076509 11076610 11086610 11086810 11086910 11096010…
FDA’s list runs to 3,790 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 22, 2020.
- FDA classified it on Jun 23, 2020.
- FDA’s Enforcement Report published it on Jul 1, 2020.
- FDA terminated it on Aug 29, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Tosoh Bioscience Inc, of Grove City, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,790 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.