The Recall Desk
HighFDA (Devices)·Z-2424-2021·Announced 2021-09-15

Atellica IM Diagnostic Test Kit Recalled for Calibration Interval Deficiency

Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.

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 in vitro diagnostic device where the product does not maintain the claimed calibration interval, creating risk of inaccurate test results. Although no illnesses or injuries have been reported, diagnostic inaccuracy poses a risk of harm through incorrect patient management decisions.

Plain-English summary

The Atellica IM BR 27.29 (BR) Assay 50 Test Kit is an in vitro diagnostic device manufactured by Siemens Healthcare Diagnostics that measures cancer antigen CA 27.29 in blood serum and plasma. It is used in clinical laboratories to support cancer monitoring.

The manufacturer discovered that the kit does not maintain calibration for the full 10-day interval claimed in the Instructions for Use. To ensure accurate test results, the calibration interval has been shortened from 10 days to 3 days for all current and future kit lots.

The recall affects 580 units distributed worldwide, including the United States, Australia, Bahamas, India, Mexico, Saudi Arabia, and Vietnam. Affected lot numbers include 40476255 and 64505255 (expiring August 3, 2021), and 89332257 and 05694257 (expiring November 10, 2021).

Laboratories using affected kits should immediately follow the updated instructions requiring calibration every 3 days instead of every 10 days, as provided in the revised Instructions for Use from Siemens Healthcare Diagnostics.

The recalled product

Product
Atellica IM BR 27.29 (BR) Assay 50 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: 10995478
Manufacturer
Siemens Healthcare Diagnostics, Inc
Category
Medical Device — In Vitro Diagnostic Test
Hazard
  • calibration-drift
  • inaccurate-results

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 numbers: 89332257 & 05694257 expiration date 2021-11-10.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category