RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for
FDA device recall Z-1255-2015 · posted 2015-03-06 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- 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.
- Action taken
- An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers. In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQM
- Quantity affected
- 2863 devices
- Distribution
- Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, C
- Date initiated
- 2014-12-30
- Date posted
- 2015-03-06
- Date terminated
- 2017-08-02
- Location
- Norwood, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (K073537) | Siemens Medical Solutions Diagnostics | 2008-06-27 |