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
Class II · Ongoing
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
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Affected lots / codes — check yours against thisUDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31; 9520341 Exp. Date: 2024-03-31
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 447 unit US; 1537 units OUS
- 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¿…
- Recall initiated
- April 5, 2023
- Classified
- May 25, 2023
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1631-2023%22
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1631-2023%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
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