ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.

Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Cal…

Recall #: Z-2135-2013
Affected scope: US: 1546 units; Foreign: 518 units
Initiated: July 30, 2013

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

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Siemens Healthcare Diagnostics recalled ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: AD… - a moderate-severity action.

ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: AD… was recalled by Siemens Healthcare Diagnostics in September 11, 2013. Reason: Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for pa…. Check the official notice for the remedy. Verify recall #Z-2135-2013 with the FDA Devices before acting.

The recall

Siemens Healthcare Diagnostics issued this moderate-severity FDA Devices recall-Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for pa….

Moderate
severity level: Class II
classification: September 11, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2135-2013 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

ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems.

Reason for recall

Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use ¿ 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..

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-2135-2013
Date reported	September 11, 2013
Date initiated	July 30, 2013
Recalling firm	Siemens Healthcare Diagnostics
Firm location	Tarrytown, NY
Affected scope	US: 1546 units; Foreign: 518 units
Distribution	Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, …

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-2135-2013) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 11, 2013. Severity: Moderate. Recall number: Z-2135-2013.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and Vietnam..

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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This recall: FDA Devices, reported September 11, 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