Siemens Recalls Intact PTH Assay Kits Due to Negative Bias
Siemens is recalling IMMULITE 2000 Intact PTH assay kits because they may show a negative bias of up to -39% at low concentrations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic inaccuracy (negative bias) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid Hormone) assay kit, specifically lot 320. The affected kits are used for in vitro diagnostic testing to measure intact parathyroid hormone in EDTA plasma and serum.
The recall is being conducted because Siemens confirmed that the affected lot can exhibit an average negative bias of up to -39% at iPTH concentrations below 20 pg/mL when compared to a reference kit lot. This bias may affect the accuracy of test results for patients with low hormone levels.
The recall involves 2,728 kits distributed worldwide, including 565 kits in the United States and 2,163 kits in other countries. The affected lot has an expiration date of November 30, 2016. Healthcare facilities and laboratories should stop using the affected kits and contact Siemens for further instructions.
The recalled product
- Product
- SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonw
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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)
- Lot Number 320
- exp. date 2016/11/30
- UDI #s: 0063041496191032020161130 and 0063041496192732020161130
Distribution
Distributed nationwide across the United States.
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