Z-1632-2023 Class II Ongoing
FDA device recall Z-1632-2023 was initiated by Siemens Healthcare Diagnostics, Inc. on April 5, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 6546 units US; 3681 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2023
- Initiation Date
- April 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6546 units US; 3681 units OUS
Product Description
Reason for Recall
Distribution Pattern
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