Diagnostic reagent kit recall: potential test result inaccuracy
Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.
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: FDA Class II device with potential for test result inaccuracy and compromised diagnostic reliability. No reported illnesses, injuries, or adverse events; the hazard is theoretical. Per the rubric, theoretical risks of harm without reported injuries score at most 3.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 19,544 units of the Atellica CH Gamma-Glutamyl Transferase (GGT) reagent kit for in vitro diagnostic use. The affected product is used to measure gamma-glutamyl transferase levels in human serum and plasma samples.
The recall addresses a potential for reagent carryover within the Atellica CH 930 analyzer. This carryover could result in a positive bias in test results, potentially affecting the accuracy of quality control samples, patient samples, and calibrator results. The defect may also impact results from related tests: Total Bilirubin, LDL Cholesterol, and HDL Cholesterol.
All lot numbers of the affected product are included in this recall. The product has been distributed nationwide in the United States as well as internationally to Taiwan, Uruguay, and Vietnam.
Laboratories and healthcare facilities using this product should contact Siemens Healthcare Diagnostics for instructions on how to proceed. No adverse events or patient injuries have been reported in connection with this issue.
The recalled product
- Product
- Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 19,544
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)
- Unique Device Identification (UDI): 00630414596440 All Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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