Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension c

FDA device recall Z-0420-2015 · posted 2014-11-21 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.

Action taken

Siemens sent an Urgent Medical Device Correction letter dated September 2014 was provided to all Dimension Vista HbA1c and Dimension HB1C customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers. Customers were instructed to discontinue use of and discard the affected devices. Customers need to review the letter with their Medical Director. Siemens will replace any unused inventoryof the affected lots at no charge. Customers were asked to complete the attached form and fax it to 302-631-7795. Customers should retain a copy of the letter with their laboratory records, and forward the letter to those who may have received this product. Customers with questions should contact their Siemens Customer Care Center - Technical Solutions or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LCP

Quantity affected

53, 046

Distribution

Worldwide Distribution: US (nationwide) and internationally to: Canada.

Date initiated

2014-09-30

Date posted

2014-11-21

Date terminated

2015-08-10

Location

Newark, DE

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