Siemens Healthcare Diagnostics, Inc. Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch 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
Products Sold
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
Siemens Healthcare Diagnostics, Inc. is recalling Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026 due to 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 At. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026