Recall Z-0124-2022— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0124-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-28

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2021-09-28. It names one FDA 510(k) clearance: K151792. Product: Atellica IM 1300 Analyzer, SMN 11066001. Reason: Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-09-28
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc.·cleared 2015-11-20

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 1300 Analyzer, SMN 11066001

Reason for recall

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

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