RecallRadar

FDA Device recall Z-2635-2017

Access Total T3, A34435H, Catalog No. 33830

On 2017-07-05 the FDA classified a Class II recall of Access Total T3, A34435H, Catalog No. 33830 by Beckman Coulter, citing the Access immunoassays are susceptible to biotin interference.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2635-2017
ClassificationClass II
Statusterminated
Initiated2017-05-09
Published2017-07-05
Last updated2026-09-13 11:54 UTC
CompanyBeckman Coulter
DistributionGA, PR

Product

Access Total T3, A34435H, Catalog No. 33830

Reason

The Access immunoassays are susceptible to biotin interference.

Identifiers

code_infoall lots

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2635-2017%22

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