ModerateClass IITerminated

FDA Devices recall · Reported March 27, 2013

Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 27, 2013. Severity: Moderate. Recall number: Z-0957-2013.

Q: Where was the recalled product distributed?

Distribution: 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..

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 customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low reco…

Recall #: Z-0957-2013
Affected scope: 2,976
Initiated: November 27, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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

Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is use… was recalled by Siemens Healthcare Diagnostics, Inc. in March 27, 2013. Reason: Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot F…. Check the official notice for the remedy. Verify recall #Z-0957-2013 with the FDA Devices before acting.

The recall

Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot F….

Moderate
severity level: 3K units
affected scope: Class II
classification: March 27, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0957-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

Reason for recall

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

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-0957-2013
Date reported	March 27, 2013
Date initiated	November 27, 2012
Recalling firm	Siemens Healthcare Diagnostics, Inc.
Firm location	Newark, DE
Affected scope	2,976
Distribution	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.

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

Scale of Impact

2,976 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

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-0957-2013) 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? ▼

Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 2,976.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 27, 2013. Severity: Moderate. Recall number: Z-0957-2013.

Where was the recalled product distributed? ▼

Distribution: 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..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported March 27, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026