Official recall record
Access Intact PTH
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-29
- Country of alert
- Canada
- Alert level
- Type I
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.