Agency classClass IIIOur severity:Low FDA (Devices)·Z-0212-2015·Announced 2014-11-19

Siemens IMMULITE Calcitonin Control Module Recalled for Typographical Error

Siemens Healthcare Diagnostics is recalling the IMMULITE Calcitonin Control Module due to a typographical error in the expiration date on the instructions for use.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation error (typographical error in expiration date) rather than a physical hazard.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE Calcitonin Control Module, which is used for in vitro diagnostic testing on IMMULITE Systems Analyzers. The recall was initiated because a typographical error regarding the expiration date was identified in the control module's instructions for use.

The affected units are identified by Catalog Number LCLCM, Lot Number 0019, and Siemens Material Number 10385383. The source text indicates that 2,212 units were distributed, with 92 units distributed domestically in the United States and 2,120 units distributed internationally. Domestic distribution included the states of Florida, Kentucky, Minnesota, Massachusetts, Pennsylvania, Utah, New York, Virginia, and California.

This is a Class III recall, which the FDA defines as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Users should refer to the instructions for use or contact Siemens Healthcare Diagnostics for further information regarding the correction of the expiration date.

The recalled product

Product: IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling

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 (7)

Catalog Number: LCLCM
Lot Number: 0019
Siemens Material Number: 10385383
IFU Reference: PILCLCM-11 {24}
2014-02-19
PINLCLCM-11{24}
PIELCLCM-9{24}

Distribution

Distributed in 9 states:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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