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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Diluent

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 Class 2 Device Recall Atellica CH Diluentsee related information
Date Initiated by FirmMay 22, 2025
Date PostedJune 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2027-2025
Recall Event ID 96952
510(K)NumberK151767 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductProduct: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Code Information Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactJennifer Sacks
443-793-7288
Manufacturer Reason
for Recall		Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn May 22, 2025 URGENT FIELD SAFETY NOTICE letters were sent to OUS customers and URGENT MEDICAL DEVICE CORRECTION letters were sent to US customers. Customer Actions Please discontinue use of and discard all inventory of the diluent lot number listed in the table above (Products Section). If lot number 0000195412 is currently on your analyzer, remove the bottle and replace with an alternate lot number. See Appendix for detailed instructions. Review your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in Commerce1,625 units (1450 US, 175 OUS)
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Bahamas.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJE
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