ModerateClass IITerminated

FDA Devices recall · Reported December 25, 2013

Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0517-2014.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0517-2014) 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.

Q: 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.

Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.

Recall #: Z-0517-2014
Affected scope: 13,751
Initiated: April 25, 2013

Compiled from official public sources by the editorial team. · Updated July 2026

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Siemens Healthcare Diagnostics, Inc. recalled Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro dia… - a moderate-severity action.

Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro dia… was recalled by Siemens Healthcare Diagnostics, Inc. in December 25, 2013. Reason: Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imp…. Check the official notice for the remedy. Verify recall #Z-0517-2014 with the FDA Devices before acting.

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The recall

Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imp….

Moderate
severity level: 14K units
affected scope: Class II
classification: December 25, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0517-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0517-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on April 25, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Newark, DE. Federal records list the affected scope as 13,751.

The documented reason for this recall is: Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results. Distribution data in the federal record shows the product reached: Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.. 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.

Where this recall sits in the database

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.

Severity

Moderate

Affected scope

13,751

Related Recalls

3 from same agency

Product description

Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients

Reason for recall

Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0517-2014
Date reported	December 25, 2013
Date initiated	April 25, 2013
Recalling firm	Siemens Healthcare Diagnostics, Inc.
Firm location	Newark, DE
Affected scope	13,751
Distribution	Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

13,751 units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0517-2014) 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? ▼

Why was this product recalled? ▼

Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0517-2014.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0517-2014) 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 December 25, 2013. 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.