Access Total T4 thyroxine assay recalled for test imprecision
Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with diagnostic imprecision that may cause erroneous or delayed test results. No illnesses or injuries reported. Risk-of-harm from diagnostic inaccuracy without confirmed patient harm indicates High severity.
Plain-English summary
Access Total T4 (REF 33800) is an in vitro diagnostic reagent assay manufactured by Beckman Coulter, Inc. It is used to measure total thyroxine (T4) levels. The company has recalled four specific lots of this reagent.
Four lots of the Access Total T4 reagent demonstrated imprecision that exceeded the 10% specification limit. This imprecision may result in erroneous or delayed thyroid test results, potentially affecting the accuracy of patient diagnoses.
Approximately 64,009 kits were distributed worldwide. Affected lot numbers are 338555 (expiration July 31, 2024), 338556 (expiration August 31, 2024), 338734 (expiration September 30, 2024), and 338958 (expiration October 31, 2024). The kits were distributed to laboratories in the United States, Puerto Rico, and 34 additional countries.
Healthcare providers and laboratory professionals should immediately check their inventory for affected lot numbers and discontinue use of any recalled kits. No illnesses or injuries related to this recall have been reported. Contact Beckman Coulter for further guidance.
The recalled product
- Product
- Access Total T4, REF 33800, IVD, thyroxine reagent assay.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 64,009
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
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