FDA Device Recall Z-0125-2022: Siemens Healthcare Diagnostics, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0125-2022.

Recall Res Number

Z-0125-2022

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc

FEI Number

1219913

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2021-09-28

Date Posted

N/A

Date Terminated

N/A

Product Code

JJE

Event Number

88792

Product Quantity

1733

Product Description Atellica IM 1600 Analyzer, SMN 11066000

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.

Action Details On September 27, 2021, the firm initiated notifications to affected customers. Customer distribution included all customers located in a city at an altitude of 350 meters (1148 feet) or higher. Customers were informed that 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 350 (m) or 1148 (ft) above sea level. The letters provide directions for mitigating the potential for leakage. If you have any questions, contact your local Siemens Healthineers technical support representative.

Distribution Pattern Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.

Code Information / Serial Numbers All units.

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Medical Device Recall: Z-0125-2022

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer