Recall Z-0625-2014
Siemens Healthcare Diagnostics, Inc. · initiated April 22, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Codes / lots: Catalog number DF105A (Siemens Material Number 10483822) - Lot numbers GA3099, exp. 4/9/13; GA3141, exp. 5/21/13; GA3197, exp. 7/16/13; GA3247, exp. 9/4/13; GA3113, exp. 4/23/13; GA3162, exp. 6/11/13; GB3211, exp. 7/30/13; GA3267, exp. 9/24/13; GA3134, exp. 5/14/13; GA3169, exp. 6/18/13; GA3232, exp. 8/20/13; GB3281, exp. 10/8/13, GC3302, exp. 10/29/13.
Reason for recall
Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
FDA-determined cause: Process control
Action taken
Siemens sent an Urgent Medical Device Recall letter in April 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discard any remaining inventory of the affected product. Siemens will replace any unused inventory at no charge. Customers were asked to complete the attached form and fax it to 302-631-8467 to indicate they have received the information. Customers were asked to retain the letter with their laboratory records and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 1-800-441-9250.
Details
- Recall number
- Z-0625-2014
- Initiated
- April 22, 2013
- Posted by FDA
- January 3, 2014
- Terminated
- February 12, 2014
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 11006 Total
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0626-2014 Class II | HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the…Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range"… | 04/22/2013Terminated |