The Recall Desk
HighFDA (Devices)·Z-2425-2021·Announced 2021-09-15

Medical Device Test Kit Requires More Frequent Calibration Than Labeled

Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.

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 FDA Class II medical device with a performance deficiency in calibration intervals. Although no illnesses or injuries have been reported, inaccurate calibration of a cancer antigen marker test could result in unreliable diagnostic results and potential patient harm. This qualifies as a risk-of-harm product category without reported injury.

Plain-English summary

Siemens Healthcare Diagnostics has recalled the Atellica IM BR 27.29 (BR) Assay 250 Test Kit, an in vitro diagnostic device used to measure cancer antigen CA 27.29 levels in human blood samples. The recall affects 437 units with lot numbers 48553255, 78009255, and 90311257.

The product does not meet the calibration performance described in its Instructions for Use (IFU). The instructions claim a calibration interval of 10 days, but the device requires recalibration every 3 days. Siemens updated the IFU to reflect the correct 3-day calibration interval for all current and future kit lot numbers.

The device is distributed worldwide, including in the United States, Australia, Bahamas, India, Mexico, Saudi Arabia, and Vietnam. Healthcare facilities and laboratories using affected lots should obtain the updated Instructions for Use from Siemens and adjust their calibration protocols accordingly.

The recalled product

Product
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- 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: 10995477
Manufacturer
Siemens Healthcare Diagnostics, Inc
Category
Medical Device — In Vitro Diagnostic - Cancer Marker
Hazard
  • calibration-deficiency
  • diagnostic-inaccuracy
  • 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: 90311257 expiration date 2021-11-10.

Distribution

Distributed nationwide across the United States.

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