Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift
Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.
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: The recall involves a risk-of-harm product (medical device) where the hazard is the potential for falsely elevated patient results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Laboratories is recalling specific lots of ARCHITECT Intact PTH Controls. The recall involves 9,463 control kits under List Number 8K25-10. The affected lots were distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
The recall was initiated because Abbott confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with the impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and control lots. This issue may also impact established ARCHITECT Intact PTH reference ranges.
The affected product consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. The preservatives include sodium azide and ProClin 300. The product is used for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
The recalled product
- Product
- ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminesc
- Manufacturer
- Abbott Laboratories
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 (14)
- List Number: 8K25-10. Lot Numbers and Expiration Dates: Lot 00713I000
- Expires 05 SEP 2014
- Lot 01813C000
- Expires 14 MAR 2014
- Lot 01813K000
- Expires 12 NOV 2014
- Lot 02613E000
- Expires 09 MAY 2014
- Lot 01412K000
- Expires 12 NOV 2013
- Lot 00713A000
- Expires 08 JAN 2014
- Lot 01012F000
- Expires 30 MAY 2013.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abbott Laboratories 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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