Siemens Healthcare Diagnostics, Inc.: Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Recall number

Z-2405-2020

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Status

Open, Classified

Initiated

2020-05-07

Posted

2020-06-19

Terminated

not on file

Reason

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

Root cause

Employee error

Action

On May 7, 2020, Siemens Healthcare Diagnostics sent an Urgent Medical Device Correction letter to their Atellica Solution IM1300/IM1600 Analyzer customers. The letter described the precautions to be taken when using the following sample containers: Atellica Tube Top Sample Cups - Siemens SMN 11069061 1mL, the Atellica Tube Top Sample Cups - Siemens SMN 11069062 2mL, and the Sarstedt 62.612 - 15.3 x 92 False Bottom sample tubes. The letter states the following about using any of the identified sample containers: the IM Analyzer has a minimum required sample volume for any reportable result; the volume depends on the sample volume for the assay, the sample volume to prime the sample tip, and the volume of unusable sample for the sample container. In addition, the firm explained that detailed information on how to calculate the minimum required sample volume is available in the Atellica Operator Guide SMN 11069101 Section 9 Sample Management. Siemens recommends following the operating instructions, ensuring that there is sufficient sample available in any sample container, and reviewing the letter with their Medical Director. The firm requested that each consignee complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days and stated that if the noted sample containers are not in use in the consignee's laboratory then, no action is required beyond completion of the Field Correction Effectiveness Check Form. *** Updated 5/3/21 *** On January 27, 2021, the firm distributed Revision B of the recall notice to US customers. The notice described updated instructions regarding system labeling for the issue and actions customers need to take in order to prevent the issue from occurring. Specifically, detailed information on how to calculate the minimum required sample volume is available in the Atellica Operator Guide SMN 11069101 V1.20, Section 9 Sample Management or V1.23 Section 12, Samples, chapter: Sample Volume Requir

Quantity

1329

Distribution

Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.

Lot, serial or model codes

Atellica Tube Top Sample Cups, 1 mL, SMN 11069061;  Atellica Tube Top Sample Cups, 2 mL, SMN 11069062;  Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL

510(k) numbers

["K151792"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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