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Immulite 2000 system-human chorionic gonadotropin (hcg) assay
Official notice
28 Mar 2022
Last checked
28 Mar 2022
An official Health Canada notice concerns Immulite 2000 system-human chorionic gonadotropin (hcg) assay. Siemens Healthcare Diagnostics Inc. Has confirmed the potential for falsely elevated hcg results due to sample carryover. This can be observed when a sample is assayed for HCG immediately after an undiluted sample with a HCG value of GT;5000 MIU/mL. This issue impacts serum and urine patient samples, as well as quality control samples and adjustors. The effect of carryover varies based on the concentration of the high HCG sample. Recall start date: Mar 1, 2022 Published 2022-03-28.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64028
Official notice
2022-03-28
The hazard
The hazard
Siemens Healthcare Diagnostics Inc. Has confirmed the potential for falsely elevated hcg results due to sample carryover. This can be observed when a sample is assayed for HCG immediately after an undiluted sample with a HCG value of GT;5000 MIU/mL. This issue impacts serum and urine patient samples, as well as quality control samples and adjustors. The effect of carryover varies based on the concentration of the high HCG sample. Recall start date: Mar 1, 2022
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Siemens, Immulite 2000 System-human Chorionic Gonadotropin Assay.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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