Siemens ADVIA Chemistry Lipase Reagent Recalled for Carryover Contamination
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase Reagent because carryover from other reagents can cause falsely elevated test results.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when they involve significant diagnostic errors that could impact patient care.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Lipase Reagent, Catalog Number B01-4840-01. The recall affects 7,814 units with Lot Numbers 318706 and 332463, which have expiration dates of June 30, 2015, and August 31, 2015. The product was distributed nationwide in the United States and to numerous countries worldwide.
A Siemens internal investigation confirmed that the reagent's current contamination avoidance settings do not prevent carryover. This carryover can result in falsely elevated ADVIA Chemistry Lipase outlier results when the reagent is run alongside Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.
This recall is classified as Class II by the FDA. Users should stop using the affected reagent and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7,814
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 (6)
- Catalog Number: B01-4840-01
- Material Number (SMN)10311896
- Lot Numbers: 318706
- 332463
- expiration dates 2015-06-30
- 2015-08-31
Distribution
Distributed nationwide across the United States.
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