Siemens Dimension HB1C Flex reagent cartridge recall
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an…
Why was Siemens Dimension HB1C Flex reagent cartridge recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot Numbers 13294BA 13308BA 13329AA 13350AA 14006AA 14041BA 14069BB 14083BA Siemens Dimension HB1C Flex reagent cartridge: Catalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers GA4266 BA4273 BA4280 BA4287 GA4301 GA4315 GC4322 GA4343 GA4350 GA4357 GA5013 GA5020
- Product
- Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 53, 046
- Distribution
- Worldwide Distribution: US (nationwide) and internationally to: Canada.
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)