The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2637-2017·Announced 2017-07-05

Beckman Coulter Access System-Free T4 Assay Recalled for Biotin Interference

Beckman Coulter is recalling Access System-Free T4 Assay kits because they are susceptible to biotin interference, which may affect test 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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical diagnostic) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Beckman Coulter Inc. is recalling the Access System-Free T4 Assay, B01902E, Catalog No. 33880. The recall involves 1,154,084 units total, with 167,035 units distributed in the United States. The product was distributed to numerous countries worldwide, including the United States, Canada, and various nations in Europe, Asia, Africa, and South America.

The recall is being conducted because the Access immunoassays are susceptible to biotin interference. This susceptibility may impact the accuracy of the assay results. The recall covers all lots of the affected product.

Healthcare facilities and laboratories should stop using the affected Access System-Free T4 Assay kits and contact Beckman Coulter for further instructions on handling the recalled product.

The recalled product

Product
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

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 (1)

  • all lots

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

See all →

Same hazard · biotin interference

See all →

Similar recalls