Agency classClass IIOur severity:High FDA (Devices)·Z-2135-2013·Announced 2013-09-11

Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias

Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a significant positive bias in diagnostic test results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, due to a positive bias of up to 12% in HbA1c test results. The issue affects patient and CAP survey samples when using specific calibrator lots. The bias is caused by over-recovery, which exceeds the 7% acceptance criteria used for established ranges of CAP Survey Samples and IFCC sample recoveries.

The recall involves 1,546 units in the United States and 518 units distributed internationally. Affected lots include 1MD014 (expiration date 5/01/2013), 1BD063 (expiration date 5/01/2013), and 2GD014 (expiration date 10/01/2014). The products were distributed nationwide in the US, in Puerto Rico, and in numerous countries worldwide.

The issue may not have been detected depending on quality control limits. Siemens confirmed the bias during testing to confirm customer complaints. Users of these calibrators should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.

The recalled product

Product: 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…
Manufacturer: Siemens Healthcare Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lots 1MD014 (exp. date 5/01/2013)
1BD063 (exp. 5/01/2013)
2GD014 (exp. 10/01/2014)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Siemens Healthcare Diagnostics

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Same hazard · mis labeling