Recall Z-2425-2021— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2425-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-06

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2021-07-06. It names one FDA 510(k) clearance: K982680. Product: 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: 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.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-07-06
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYChiron Diagnostics Corp.·cleared 1998-10-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.