Beckman Coulter, Inc. recalls Access Total T4 Calibrator, Catalog No. 33805
See all recalls from Beckman Coulter, Inc. →Recalled Product
Access Total T4 Calibrator, Catalog No. 33805
Hazard / Issue
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Issued by
FDA
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Access Total T4 Calibrator, →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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