Atellica CH Diluent Recalled Due to Sodium Hypochlorite Contamination
Siemens is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect calibrator, quality control, and patient test results. The recall affects 1,625 units distributed in the United States, Canada, and the Bahamas.
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: FDA Class II medical device recall involving confirmed contamination of a laboratory diluent that may affect test accuracy across multiple assays. While no illnesses or injuries have been reported, the potential to produce inaccurate laboratory results poses a risk to patient care and diagnosis.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Diluent - CONS 2 x 1.5L (Siemens Material Number 11099300). The recall involves lot number 0000195412 and affects a total of 1,625 units.
The diluent has been contaminated with sodium hypochlorite, which may impact the accuracy of test calibrators, quality control results, and patient test results for all laboratory assays except those measuring sodium, potassium, and chloride levels.
The affected product was distributed worldwide, with 1,450 units in the United States and 175 units in Canada and the Bahamas. Laboratories and healthcare facilities currently using this product should contact Siemens Healthcare Diagnostics, Inc. regarding this recall.
The recalled product
- Product
- Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- chemical-contamination
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 (3)
- Siemens Material Number (SMN): 11099300
- UDI-DI: 00630414595771
- Lot Number: 0000195412
Distribution
Distributed nationwide across the United States.
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