Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level …

Recall #: Z-0648-2013
Affected scope: Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)
Initiated: November 28, 2012

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

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Siemens Healthcare Diagnostics recalled Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantit… - a low-severity action.

Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantit… was recalled by Siemens Healthcare Diagnostics in January 16, 2013. Reason: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values wi…. Check the official notice for the remedy. Verify recall #Z-0648-2013 with the FDA Devices before acting.

The recall

Siemens Healthcare Diagnostics issued this low-severity FDA Devices recall-The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values wi….

Low
severity level: Class III
classification: January 16, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0648-2013 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 low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Reason for recall

The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	Z-0648-2013
Date reported	January 16, 2013
Date initiated	November 28, 2012
Recalling firm	Siemens Healthcare Diagnostics
Firm location	Tarrytown, NY
Affected scope	Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)
Distribution	Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,

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-0648-2013) and product description against the item you own. Search the archive
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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? ▼

Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.. Recalled by Siemens Healthcare Diagnostics. Units affected: Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees).

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 16, 2013. Severity: Low. Recall number: Z-0648-2013.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,.

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 (Low), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported January 16, 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