Recall Z-2913-2016— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2913-2016
Creator: U.S. Food and Drug Administration
Published: 2016-09-02

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2016-09-02, terminated 2017-08-07. It names one FDA 510(k) clearance: K110277. Product: Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469. Reason: Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge.

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class III
Status: Terminated
Initiated: 2016-09-02
Terminated: 2017-08-07
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K110277 — RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare Diagnostics·cleared 2011-08-15

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

Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

Reason for recall

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

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