Recall Z-1421-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1421-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-12

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-01-12. It names one FDA 510(k) clearance: K161954. Product: Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143. Reason: Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-01-12
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics·cleared 2017-03-09

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 CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Reason for recall

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

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