Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated…
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not…
Read the official notice →- Date
- 2024-09-18
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from…
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FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide.Official notice → - 2024-09-25
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FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL,…Official notice → - 2024-07-03
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Other drugs & medical recalls in the United States
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MEDLINE INDUSTRIES, LP - Northfield recalls Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B;…
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