Recall record at a glance
| Official record | Z-0957-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Mar 27, 2013 |
| Recall initiation date | Nov 27, 2012 |
| Quantity | 2,976 |
| Location | Newark, DE, United States |
Official product description
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Why the product was recalled
Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values
Distribution information
Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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