Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 22, 2023
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 an…
Siemens Healthcare Diagnostics, Inc. recalled Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quanti… - a moderate-severity action.
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quanti… was recalled by Siemens Healthcare Diagnostics, Inc. in March 22, 2023. Reason: Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and …. Check the official notice for the remedy. Verify recall #Z-1258-2023 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and ….
- Moderate
- severity level
- 6K units
- affected scope
- Class II
- classification
- March 22, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1258-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1258-2023) was formally reported on March 22, 2023, with the manufacturer initiating the action on January 30, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as 6035 units.
The documented reason for this recall is: Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of err… Distribution data in the federal record shows the product reached: Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile Colombia Country India Japan New Zealand Nicaragua Saudi¿Arabia¿¿¿ South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Taiwan. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6035 units
Related Recalls
6
3 from same agency
Product description
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
Reason for recall
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1258-2023 |
| Date reported | March 22, 2023 |
| Date initiated | January 30, 2023 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Tarrytown, NY |
| Affected scope | 6035 units |
| Distribution | Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile Colombia Country India Japan New Zealand Nicaragua Saudi¿Arabia¿¿¿ South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Taiwan |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1258-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207). Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 6035 units.
Why was this product recalled? ▼
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1258-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile Colombia Country India Japan New Zealand Nicaragua Saudi¿Arabia¿¿¿ South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Taiwan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1258-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 22, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.