Day

April 10, 2025
10
Apr

FDA Recall: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

April 10, 2025
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/10/2025 Class II PRODUCT Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223 Recall Number: Z-1551-2025 REASON: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. RECALLING FIRM/MANUFACTURER: Siemens Healthcare Diagnostics, Inc. VOLUME: N/A DISTRIBUTION: Domestic:...
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