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Atellica Solution IM1600 Analyzer, Siemens Material Number… recallZ-2405-2020 · Siemens Healthcare Diagnostics, Inc. · initiated May 7, 2020

Class II Open, Classified All recalls posted in June 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Employee error

What the company is doing

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

Recall details

Recall number
Z-2405-2020
Recall class
Class II
Status
Open, Classified
Initiated by the company
May 7, 2020
Posted by the FDA
Jun 19, 2020
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1329
Product code
JJE
FDA submissions
K151792
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.

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

2 devices cleared under K151792 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85687).

Sources and updates

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