Recall Z-1231-2015— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1231-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-27

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2015-01-27, terminated 2016-03-31. It names one FDA 510(k) clearance: K932955. Product: ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.. 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).

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-27
Terminated: 2016-03-31
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K932955 — CIBA CORNING ACS PROGESTERONE IMMUNOASSAYCiba Corning Diagnostics Corp.·cleared 1993-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.