Medical Device Calibrator Recall for Salicylate Assay Due to Measurement Bias
Siemens Healthcare is recalling ADVIA Chemistry ToxAmmonia Calibrators due to positive bias in salicylate assay measurements. Affected calibrators were distributed across the US and internationally.
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 an FDA Class II recall without reported illnesses or injuries. The positive bias in calibration represents a theoretical hazard of inaccurate test results that could affect clinical decision-making. Per the rubric, recalls without reported patient harm and with theoretical hazards score at most 3 (High).
Plain-English summary
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry ToxAmmonia Calibrators used for in vitro diagnostic testing. The calibrators are used to calibrate assays that measure ethanol, ammonia, acetaminophen, and salicylate on ADVIA Chemistry systems (Siemens Material Number 10309217).
The recall was issued due to positive bias detected in the calibration measurements for the salicylate assay. A positive bias means the calibrator produces measurements that are higher than the actual values, which could lead to inaccurate test results and potentially incorrect clinical decisions based on those measurements.
A total of 447 units were distributed in the US and 1,537 units were distributed internationally across numerous countries including Canada, Europe, Asia, Latin America, and the Middle East. The affected lot numbers are 9520531 (expiration date May 31, 2023) and 9520341 (expiration date March 31, 2024).
Healthcare facilities and laboratories using these calibrators should discontinue use of the affected lot numbers immediately and contact Siemens Healthcare Diagnostics for instructions regarding replacement or proper disposal of recalled units.
The recalled product
- Product
- ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (2)
- UDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31
- 9520341 Exp. Date: 2024-03-31
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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