—#181542

Product

Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K151792
Affected lot / code info: 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

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 IM1600 analyzers.

Root cause (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-05-07
Posted by FDA: 2020-06-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.