Recall Z-1800-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1800-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-12

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-03-12, terminated 2020-06-02. It names one FDA 510(k) clearance: K102779. Product: Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440. Reason: Incorrect calibrator level listed in qualitative calibration steps.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2018-03-12
Terminated: 2020-06-02
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K102779 — EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY CSiemens Healthcare Diagnostics, Inc.·cleared 2011-03-18

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

Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440

Reason for recall

Incorrect calibrator level listed in qualitative calibration steps

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