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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 437
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.
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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