Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
Reported: September 15, 2021 Initiated: July 6, 2021 #Z-2425-2021
Product Description
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
Reason for Recall
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 437 units
- Distribution
- Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 437 units.
Why was this product recalled? ▼
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 15, 2021. Severity: Moderate. Recall number: Z-2425-2021.
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