The Recall Desk
HighFDA (Devices)·Z-2426-2021·Announced 2021-09-15

Medical diagnostic kit requires more frequent calibration than Instructions stated

The Instructions for Use for Siemens' Atellica IM BR 27.29 Test Kit incorrectly specified a 10-day calibration interval instead of 3 days. The manufacturer has updated the instructions for all kit lots.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device used for cancer antigen detection. While no illnesses or injuries have been reported, the incorrect calibration interval in the Instructions for Use represents a risk-of-harm scenario—inaccurate calibration schedules could result in degraded diagnostic accuracy. Under the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM BR 27.29 Assay 250 Test Kit, which is used for in vitro diagnostic testing to measure cancer antigen CA 27.29 levels in human blood samples. The recall is due to incorrect instructions provided with the kit.

The Instructions for Use (IFU) claimed a calibration interval of 10 days, but the correct interval is 3 days. Siemens has corrected the IFU to specify the 3-day calibration interval for all current and future kit lot numbers.

The recall affects approximately 787 units distributed worldwide, including to the United States, Australia, Bahamas, India, Mexico, Saudi Arabia, and Vietnam. Affected lot numbers include 41331255, 74682255 (expiring August 3, 2021), and 91605257 (expiring November 10, 2021).

Healthcare facilities and laboratories using this product should implement the corrected 3-day calibration interval as specified in the updated instructions.

The recalled product

Product
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Manufacturer
Siemens Healthcare Diagnostics, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
  • calibration-error
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number: 91605257 expiration date 2021-11-10.

Distribution

Distributed nationwide across the United States.

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