Recall Z-1252-2015— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-1252-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-30

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2014-12-30, terminated 2017-08-02. It names one FDA 510(k) clearance: K110277. Product: RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.. Reason: Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2014-12-30
Terminated: 2017-08-02
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

RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.

Reason for recall

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

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