ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Number (SMN): 10309217
- Recall Initiated
- April 5, 2023
- Posted
- May 25, 2023
- Recall Number
- Z-1631-2023
- Quantity
- 447 unit US; 1537 units OUS
- Firm Location
- Tarrytown, NY
Reason for Recall
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
Distribution
US Nationwide and Worldwide Distribution Foreign: Argentina Australia Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Canada Chile China Colombia Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hong Kong Hungary¿¿¿¿¿¿¿¿ India Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Malaysia Mexico Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Republic of Korea Saudi¿Arabia¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Taiwan Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uruguay Vietnam
Lot / Code Info
UDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31; 9520341 Exp. Date: 2024-03-31
Root Cause
Under Investigation by firm
Action Taken
Siemens issued Urgent Medical Device Corrections (UMDC) ACHC23-03.A.US and ACHC23- 03.A.US.CHC to US customers via FedEx beginning on 04/05/2023. An Urgent Field Safety Notices (UFSN) ACHC23-03.A.OUS and ACHC23-03.A.OUS.CHC issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 04/05/2023. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Until the updated lot-specific value sheets are available on Document Library, keep a copy of this letter as a reference for the updated salicylate calibrator values. Perform the instructions provided in Additional Information section below. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.