Recall archive / FDA device enforcement
Access Total T4, REF 33800, IVD, thyroxine reagent assay. — FDA record Z-1303-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Access Total T4, REF 33800, IVD, thyroxine reagent assay.
- Reason
- Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 64,009 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1303-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot numbers: 338555, exp. 31 JUL 2024; 338556, exp. 31 AUG 2024; 338734, exp. 30 SEP 2024; and 338958, exp. 31 OCT 2024; UDI-DI 15099590225742. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E, Vietnam, and Zimbabwe.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 27, 2024
- Recall initiation date
- Feb 8, 2024
- Center classification date
- Mar 15, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.