Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift
Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.
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 is classified as FDA Class II, and the hazard involves a risk of harm (falsely elevated patient results) where specific injury or illness has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators. The product consists of six 4.0 mL bottles containing buffers, synthetic peptides, and stabilizers used for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
The recall was initiated because Abbott confirmed that a performance shift in the 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, which may also impact established reference ranges.
The affected products were distributed worldwide, including the United States, Puerto Rico, and numerous international locations. Specific lot numbers and expiration dates are listed in the recall documentation. Users should stop using the affected calibrators and contact Abbott Laboratories for further instructions.
The recalled product
- Product
- ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium
- Manufacturer
- Abbott Laboratories
- Affected units
- 7,780
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 (16)
- List Number: 8K25-01. Lot Numbers and Expiration Dates: Lot 00613I000
- Expires 05 SEP 2014
- Lot 01913C000
- Expires 14 MAR 2014
- Lot 01913K000
- Expires 12 NOV 2014
- Lot 02413E000
- Expires 09 MAY 2014
- Lot 01312K000
- Expires 12 NOV 2013
- Lot 00813A000
- Expires 08 JAN 2014
- Lot 01412H000
- Expires 16 AUG 2013
- Lot 00912F000
- 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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