ARCHITECT c4000 Processing Module
Medical device recall Z-0682-2024. Published in FDA’s Enforcement Report on Jan 17, 2024.
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 Jan 17, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 48 states named in where it went
- 995 systems 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 devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
995 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List Number: 02P24-01 Serial Numbers / UDI Codes: C400911 (01)00380740003746(21)C400911 C402913 (01)00380740003746(21)C402913 C460004 (01)00380740003746(21)C460004 C460033 (01)00380740003746(21)C460033 C460055 (01)00380740003746(21)C460055…
Every code shown here, 1,996 characters
List Number: 02P24-01 Serial Numbers / UDI Codes: C400911 (01)00380740003746(21)C400911 C402913 (01)00380740003746(21)C402913 C460004 (01)00380740003746(21)C460004 C460033 (01)00380740003746(21)C460033 C460055 (01)00380740003746(21)C460055 C460066 (01)00380740003746(21)C460066 C460082 (01)00380740003746(21)C460082 C460158 (01)00380740003746(21)C460158 C460200 (01)00380740003746(21)C460200 C460375 (01)00380740003746(21)C460375 C460385 (01)00380740003746(21)C460385 C460396 (01)00380740003746(21)C460396 C460397 (01)00380740003746(21)C460397 C460408 (01)00380740003746(21)C460408 C460410 (01)00380740003746(21)C460410 C460422 (01)00380740003746(21)C460422 C460435 (01)00380740003746(21)C460435 C460439 (01)00380740003746(21)C460439 C460523 (01)00380740003746(21)C460523 C460532 (01)00380740003746(21)C460532 C460588 (01)00380740003746(21)C460588 C460728 (01)00380740003746(21)C460728 C460767 (01)00380740003746(21)C460767 C460797 (01)00380740003746(21)C460797 C460798 (01)00380740003746(21)C460798 C460800 (01)00380740003746(21)C460800 C460826 (01)00380740003746(21)C460826 C460827 (01)00380740003746(21)C460827 C460830 (01)00380740003746(21)C460830 C460832 (01)00380740003746(21)C460832 C460833 (01)00380740003746(21)C460833 C460834 (01)00380740003746(21)C460834 C460846 (01)00380740003746(21)C460846 C460849 (01)00380740003746(21)C460849 C460857 (01)00380740003746(21)C460857 C460868 (01)00380740003746(21)C460868 C460875 (01)00380740003746(21)C460875 C460886 (01)00380740003746(21)C460886 C460927 (01)00380740003746(21)C460927 C460928 (01)00380740003746(21)C460928 C460939 (01)00380740003746(21)C460939 C460958 (01)00380740003746(21)C460958 C460993 (01)00380740003746(21)C460993 C461042 (01)00380740003746(21)C461042 C461092 (01)00380740003746(21)C461092 C461093 (01)00380740003746(21)C461093 C461100 (01)00380740003746(21)C461100 C461105 (01)00380740003746(21)C461105 C461112 (01)00380740003746(21)C461112 C461122 (01)00380740003746(21)C461122 C461124 (01)00380740003746(21)C461124 C461129…
FDA’s list runs to 34,333 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.
U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil
The states and territories these words name
48 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Oct 19, 2023.
- FDA classified it on Jan 8, 2024.
- FDA’s Enforcement Report published it on Jan 17, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Laboratories, of Irving, TX.
- 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 34,333 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
-
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.