RecallRadar

FDA Device recall Z-1230-2015

ADVIA Centaur Systems Progesterone Kit, (5 -pack)

On 2015-03-11 the FDA classified a Class II recall of ADVIA Centaur Systems Progesterone Kit, (5 -pack) by Siemens Healthcare Diagnostics, citing ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1230-2015
ClassificationClass II
Statusterminated
Initiated2015-01-27
Published2015-03-11
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.

Reason

ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)

Identifiers

code_infoLot Numbers: 42565268 42624268 43538268 Exp. Date: May 22, 2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1230-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.