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Access intact pth
Official notice
29 Nov 2024
Last checked
29 Nov 2024
An official Health Canada notice concerns Access intact pth. Beckman Coulter has determined that 91 Access Intact PTH reagent packs (lot 339071) were filled with an incorrect volume of reagent in well 0. Access Intact PTH patient and QC samples with a reagent pack that has less volume than expected may: - Recover up to 30% lower than the expected results for routine PTH, with a pack imprecision of up to 10%. - Recover up to 40% lower than the expected results for intraoperative PTH, with a pack imprecision of up to 15%. - Produce a zero or near-zero result. Falsely decreased Intact PTH results could lead to a delay in diagnosis, additional diagnostic testing, and/or inappropriate treatment. Recall Start Date: November 25, 2024 Published 2024-11-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76621
Official notice
2024-11-29
The hazard
The hazard
Beckman Coulter has determined that 91 Access Intact PTH reagent packs (lot 339071) were filled with an incorrect volume of reagent in well 0. Access Intact PTH patient and QC samples with a reagent pack that has less volume than expected may: - Recover up to 30% lower than the expected results for routine PTH, with a pack imprecision of up to 10%. - Recover up to 40% lower than the expected results for intraoperative PTH, with a pack imprecision of up to 15%. - Produce a zero or near-zero result. Falsely decreased Intact PTH results could lead to a delay in diagnosis, additional diagnostic testing, and/or inappropriate treatment. Recall Start Date: November 25, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Beckman Coulter, Access Intact Pth.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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